<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04428333</url>
  </required_header>
  <id_info>
    <org_study_id>209227</org_study_id>
    <secondary_id>2019-003981-42</secondary_id>
    <nct_id>NCT04428333</nct_id>
  </id_info>
  <brief_title>Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma</brief_title>
  <acronym>INDUCE-4</acronym>
  <official_title>A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in&#xD;
      combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab&#xD;
      combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic&#xD;
      (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase&#xD;
      II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum&#xD;
      chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in&#xD;
      participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx&#xD;
      or larynx.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Anticipated">July 26, 2023</completion_date>
  <primary_completion_date type="Actual">April 27, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This will be a randomized, parallel group treatment study with eligible participants receiving either GSK3359609 in combination with pembrolizumab and 5FU-platinum chemotherapy or placebo in combination with pembrolizumab and 5FU-platinum chemotherapy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This is a double blind study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS) in mITT Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>OS was defined as the time from the date of randomization to the date of death due to any cause. Kaplan-Meier estimate for the median OS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OS in Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>OS was defined as the time from the date of randomization until the date of death due to any cause. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median OS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 in mITT Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>PFS per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 was defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PFS Per RECIST v1.1 in the PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>PFS per RECIST v1.1 was defined as the time from the date of randomization until the date of disease progression or death due to any cause, whichever occurs first. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Milestone OS Rate at 12, 24 and 36 Months in mITT Population</measure>
    <time_frame>Months 12, 24 and 36</time_frame>
    <description>Milestone OS rate at 12, 24, and 36 months was not evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Milestone OS Rate at 12, 24 and 36 Months in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Months 12, 24 and 36</time_frame>
    <description>Milestone OS rate at 12, 24, and 36 months was not evaluated. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR) Per RECIST v1.1 in mITT Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>ORR per RECIST v1.1 was defined as the proportion of the participants who have a complete response (CR) or partial response (PR) as the best overall response per RECIST v1.1 based upon investigator assessment. As a randomized double-blind study in which primary endpoints are OS and PFS, the confirmation of CR and PR was not required. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR Per RECIST v1.1 in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>ORR per RECIST v1.1 was defined as the proportion of the participants who have a complete response (CR) or partial response (PR) as the best overall response per RECIST v1.1 based upon investigator assessment. As a randomized double-blind study in which primary endpoints are OS and PFS, the confirmation of CR and PR was not required. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR) Per RECIST v1.1 in mITT Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>DCR per RECIST v1.1 based upon investigator assessment, was defined as the percentage of participants with a best overall response of CR or PR at any time plus stable disease (SD) meeting the minimum time of 15 weeks. A status of SD≥15 weeks will be assigned if the follow-up disease assessment has met the SD criteria at least once after the date of randomization at a minimum of 14 weeks (98 days) considering a one-week visit window. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR Per RECIST v1.1 in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>DCR per RECIST v1.1 based upon investigator assessment, was defined as the percentage of participants with a best overall response of CR or PR at any time plus stable disease (SD) meeting the minimum time of 15 weeks. A status of SD≥15 weeks will be assigned if the follow-up disease assessment has met the SD criteria at least once after the date of randomization at a minimum of 14 weeks (98 days) considering a one-week visit window. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DoR) Per RECIST v1.1 in mITT Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>DoR per RECIST v1.1 is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. Kaplan-Meier estimate for the median DoR is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DoR Per RECIST v1.1 in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>DoR per RECIST v1.1 is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. Kaplan-Meier estimate for the median DoR is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) in Safety Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs) in Safety Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other situations according to medical or scientific judgement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events of Special Interest (AESI) in Safety Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With AEs in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With SAEs in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other situations according to medical or scientific judgement. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With AESIs in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of AEs in Safety Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity for each AE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of SAEs in Safety Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. Severity for each SAE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing SAEs of Grade &gt;= 3 have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of AESIs in Safety Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. Severity of each AESI was reported during the study and was assigned a grade according to the NCI-CTCAE. AESIs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE. Data of participants experiencing AESIs of Grade &gt;= 3 have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of AEs in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity for each AE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing AEs of Grade &gt;= 3 have been presented. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of SAEs in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. Severity for each SAE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing SAEs of Grade &gt;= 3 have been presented. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of AESI in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. Severity of each AESI was reported during the study and was assigned a grade according to the NCI-CTCAE. AESIs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE. Data of participants experiencing AESIs of Grade &gt;= 3 have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Dose Modifications in Safety Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>Number of participants with dose modifications (including dose interruptions, dose delays, dose reductions and treatment discontinuations) were reported by each interventional component.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Dose Modifications in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>Number of participants with dose modifications (including dose interruptions, dose delays, dose reductions and treatment discontinuations) were reported by each interventional component. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Deterioration (TTD) in Pain in mITT Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>TTD in pain is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the European Organization for Research and Treatment of Cancer Item Library(EORTC IL51) Questionnaire pain domain, i.e. an increase from baseline of at least 8.33 observed at all subsequent non-missing visits. The EORTC Quality of Life Questionnaire 35-Item Head and Neck Module (QLQ-H&amp;N35) is a head and neck specific module with multi-item scales. The mouth pain, swallowing, speech problems, opening mouth, coughing, feeding tube, and trouble with social eating domains were administered and referred to as the EORTC IL51. The questionnaire scores for each scale and single-item measure are averaged and transformed linearly to present a score ranging from 0-100. A high score represents a high/healthy level of functioning. Kaplan-Meier estimate for the median TTD is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TTD in Pain in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>TTD in pain is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the EORTC IL51 pain domain, i.e. an increase from baseline of at least 8.33 observed at all subsequent non-missing visits. The EORTC QLQ-H&amp;N35 is a head and neck specific module with multi-item scales. The mouth pain, swallowing, speech problems, opening mouth, coughing, feeding tube, and trouble with social eating domains were administered and referred to as the EORTC IL51. The questionnaire scores for each scale and single-item measure are averaged and transformed linearly to present a score ranging from 0-100. A high score represents a high/healthy level of functioning. Kaplan-Meier estimate for the median TTD is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells to the total number of viable tumor cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TTD in Physical Function in mITT Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>TTD in physical function (PF) is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the PF T-score, i.e. a decrease from baseline of at least 2.4 observed at all subsequent non-missing visits, as measured by the Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS PF 8c).The PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It includes a 5-point scale with three sets of response options. Scores on the PROMIS PF 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TTD in Physical Function in PD-L1 CPS ≥1 Population</measure>
    <time_frame>Up to approximately 7 months</time_frame>
    <description>TTD in PF is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the PF T-score, i.e. a decrease from baseline of at least 2.4 observed at all subsequent non-missing visits, as measured by the PROMIS PF 8c.The PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It includes a 5-point scale with three sets of response options. Scores on the PROMIS PF 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Neoplasms, Head and Neck</condition>
  <arm_group>
    <arm_group_label>Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Pembrolizumab + 5-FU-platinum chemotherapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Feladilimab</intervention_name>
    <description>Humanized anti-inducible T cell co-stimulatory receptor (ICOS) immunoglobulin G4 (IgG4) monoclonal antibody (mAb)</description>
    <arm_group_label>Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Humanized anti- programmed cell death receptor1 (anti-PD-1) IgG4 mAb</description>
    <arm_group_label>Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapy</arm_group_label>
    <arm_group_label>Placebo + Pembrolizumab + 5-FU-platinum chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sterile normal saline</description>
    <arm_group_label>Placebo + Pembrolizumab + 5-FU-platinum chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Platinum based chemotherapy</intervention_name>
    <description>Cisplatin/carboplatin</description>
    <arm_group_label>Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapy</arm_group_label>
    <arm_group_label>Placebo + Pembrolizumab + 5-FU-platinum chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorouracil (5FU)</intervention_name>
    <description>5-fluorouracil</description>
    <arm_group_label>Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapy</arm_group_label>
    <arm_group_label>Placebo + Pembrolizumab + 5-FU-platinum chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Capable of giving signed informed consent&#xD;
&#xD;
          -  Male or female, age &gt;=18 years&#xD;
&#xD;
          -  HNSCC that was diagnosed as recurrent or metastatic and considered incurable by local&#xD;
             therapies.&#xD;
&#xD;
          -  Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.&#xD;
&#xD;
          -  No prior systemic therapy administered in the recurrent or metastatic setting (with&#xD;
             the exception of systemic therapy completed &gt;6 months prior if given as part of&#xD;
             multimodal treatment for locally advanced disease and no disease&#xD;
             progression/recurrence within 6 months of the completion of curatively intended&#xD;
             systemic treatment).&#xD;
&#xD;
          -  Measurable disease per RECIST version 1.1 guidelines&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.&#xD;
&#xD;
          -  Adequate organ function.&#xD;
&#xD;
          -  Life expectancy of at least 12 weeks.&#xD;
&#xD;
          -  Female participants: must not be pregnant, not breastfeeding, and be either not a&#xD;
             woman of childbearing potential (WOCBP); or be a WOCBP who agrees to use a highly&#xD;
             effective method of birth control from 30 days prior to randomization and for at least&#xD;
             120 days after the last dose of study treatment.&#xD;
&#xD;
          -  Male participants with female partners of child-bearing potential: must agree to use a&#xD;
             highly effective contraception while receiving study treatment and for at least 120&#xD;
             days after the last dose of study treatment and refrain from donating sperm during&#xD;
             this periods.&#xD;
&#xD;
          -  Provide tumor tissue from excisional or core biopsy (fine needle aspirates and bone&#xD;
             biopsies are not acceptable) acquired within 2 years prior to randomization for PD-L1&#xD;
             immunohistochemistry (IHC) testing by central laboratory.&#xD;
&#xD;
          -  Have PD-L1 IHC CPS status by central laboratory testing.&#xD;
&#xD;
          -  Have results from testing of human papilloma virus (HPV) status for oropharyngeal&#xD;
             cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior therapy with an anti-PD-1/L1/L2, anti-Inducible T Cell Co-Stimulatory Receptor&#xD;
             (ICOS) directed agent.&#xD;
&#xD;
          -  Systemic approved or investigational anticancer therapy within 30 days or 5 half lives&#xD;
             of the drug, whichever is shorter. At least 14 days must have elapsed between the last&#xD;
             dose of prior anticancer agent and the date of randomization. - Has high risk of&#xD;
             bleeding (examples include but not limited to tumors encasing or infiltrating a major&#xD;
             vessel [i.e. carotid, jugular, bronchial artery] and/or exhibits other high-risk&#xD;
             features such as an arteriovenous fistula)&#xD;
&#xD;
          -  Active tumor bleeding - Grade 3 or Grade 4 hypercalcemia.&#xD;
&#xD;
          -  Major surgery less than or equal to (&lt;=) 28 days prior to randomization.&#xD;
&#xD;
          -  Participants must have also fully recovered from any surgery (major or minor) and/or&#xD;
             its complications before randomization&#xD;
&#xD;
          -  Toxicity from previous anticancer treatment that includes: a. Grade 3/Grade 4 toxicity&#xD;
             considered related to prior immunotherapy and that led to treatment discontinuation&#xD;
             and b. toxicity related to prior treatment that has not resolved to &lt;=Grade 1 (except&#xD;
             alopecia, hearing loss, endocrinopathy managed with replacement therapy, and&#xD;
             peripheral neuropathy which must be &lt;=Grade 2).&#xD;
&#xD;
          -  Received transfusion of blood products or administration of colony stimulating factors&#xD;
             within 14 days prior to randomization.&#xD;
&#xD;
          -  Central nervous system (CNS) metastases, with the following exception: Participants&#xD;
             with asymptomatic CNS metastases who are clinically stable and have no requirement for&#xD;
             steroids for at least 14 days prior to randomization.&#xD;
&#xD;
          -  Invasive malignancy or history of invasive malignancy other than disease under study&#xD;
             within the last 3 years with the exception of: a. any other invasive malignancy for&#xD;
             which the participant was definitively treated, has been disease-free for &lt;=3 years.&#xD;
             b. curatively treated non-melanoma skin cancer or successfully treated in situ&#xD;
             carcinoma and/or. c. low-risk early stage prostate cancer defined as: Stage T1c or T2a&#xD;
             with a Gleason score &lt;=6 and prostatic-specific antigen less than (&lt;)10 nanograms per&#xD;
             milliliter (ng/mL) either treated with definitive intent or untreated in active&#xD;
             surveillance that has been stable for the past year prior to randomization.&#xD;
&#xD;
          -  Autoimmune disease or syndrome that required systemic treatment within the past 2&#xD;
             years.&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving systemic steroids (&gt;10 milligram&#xD;
             [mg] oral prednisone or equivalent) or other immunosuppressive agents within 7 days&#xD;
             prior to randomization.&#xD;
&#xD;
          -  Receipt of any live vaccine within 30 days prior randomization.&#xD;
&#xD;
          -  Prior allogeneic/autologous bone marrow or solid organ transplantation.&#xD;
&#xD;
          -  Has current pneumonitis or history of non-infectious pneumonitis that required&#xD;
             steroids or other immunosuppressive agents.&#xD;
&#xD;
          -  Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural&#xD;
             or pericardial effusions.&#xD;
&#xD;
          -  Recent history (within the past 6 months) of gastrointestinal obstruction that&#xD;
             required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal&#xD;
             abscess.&#xD;
&#xD;
          -  Recent history of allergen desensitization therapy within 4 weeks of randomization.&#xD;
&#xD;
          -  History or evidence of cardiac abnormalities within the 6 months prior to&#xD;
             randomization which include: a. Serious, uncontrolled cardiac arrhythmia or clinically&#xD;
             significant electrocardiogram abnormalities including second degree (Type II) or&#xD;
             third-degree atrioventricular block. b. Cardiomyopathy, myocardial infarction, acute&#xD;
             coronary syndromes(including unstable angina pectoris), coronary angioplasty, stenting&#xD;
             or bypass grafting. c. Congestive heart failure (Class II, III, or IV) as defined by&#xD;
             the New York Heart Association functional classification system. d. Symptomatic&#xD;
             pericarditis.&#xD;
&#xD;
          -  Current unstable liver or biliary disease per investigator assessment defined by the&#xD;
             presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or&#xD;
             gastric varices, persistent jaundice, or cirrhosis.&#xD;
&#xD;
          -  Active infection requiring systemic therapy.&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV) infection, or positive test for hepatitis B&#xD;
             active infection (presence of hepatitis B surface antigen), or hepatitis C active&#xD;
             infection.&#xD;
&#xD;
          -  History of severe hypersensitivity to monoclonal antibodies or to the chemotherapies&#xD;
             under investigation including any ingredient used in the formulation.&#xD;
&#xD;
          -  Known history of active tuberculosis.&#xD;
&#xD;
          -  Any serious (&gt;=Grade 3) and/or unstable pre-existing medical condition (aside from&#xD;
             malignancy).&#xD;
&#xD;
          -  Any psychiatric disorder, or other condition that could interfere with participant's&#xD;
             safety, obtaining informed consent, or compliance to the study procedures in the&#xD;
             opinion of the investigator.&#xD;
&#xD;
          -  Is currently participating in or has participated in a study of an investigational&#xD;
             agent or has used an investigational device within 4 weeks prior to the date of&#xD;
             randomization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oro Verde</city>
        <state>Entre Ríos</state>
        <zip>E3100XAD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000DBS</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Miguel de Tucumán</city>
        <state>Tucumán</state>
        <zip>T4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <zip>1012</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aires</city>
        <zip>C1426ABP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Blacktown</city>
        <state>New South Wales</state>
        <zip>2148</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vitória</city>
        <state>Espírito Santo</state>
        <zip>29043-260</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Curitiba</city>
        <state>Paraná</state>
        <zip>81520-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>São Paulo</city>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Koebenhavn Oe</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lyon cedex 08</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Poitiers cedex</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Strasbourg</city>
        <zip>67200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Wuerttemberg</state>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dublin</city>
        <zip>8</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Savona</city>
        <state>Liguria</state>
        <zip>17100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brescia</city>
        <state>Lombardia</state>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Prato</city>
        <state>Toscana</state>
        <zip>59100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Daegu-si</city>
        <zip>42601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hwasun-gun, Jeollanam-do</city>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gdynia</city>
        <zip>81-519</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gliwice</city>
        <zip>44-102</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tomaszow Mazowiecki</city>
        <zip>97-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>021389</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cluj Napoca</city>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Craiova</city>
        <zip>200347</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Floresti</city>
        <zip>407280</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Otopeni</city>
        <zip>075100</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Suceava</city>
        <zip>720284</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pushkin</city>
        <zip>196603</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-171 64</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>China</country>
    <country>Taiwan</country>
  </removed_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>April 27, 2022</results_first_submitted>
  <results_first_submitted_qc>April 27, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 25, 2022</results_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GSK3359609</keyword>
  <keyword>Pembrolizumab</keyword>
  <keyword>Programmed cell death receptor 1</keyword>
  <keyword>Inducible T cell co-stimulatory receptor</keyword>
  <keyword>Keynote-A02</keyword>
  <keyword>Phase II/III</keyword>
  <keyword>Platinum-based chemotherapy</keyword>
  <keyword>5FU</keyword>
  <keyword>Head and neck squamous cell carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>http://clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT04428333/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT04428333/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment in the study stopped after interim safety/efficacy data review by the Independent Data Monitoring Committee, after a pre-specified futility analysis of the 209229 (NCT04128696) trial. A Dear investigator letter (DIL) was issued to stop screening &amp; randomization of more subjects in both studies. Participants discontinued feladilimab/placebo, but treatment with pembrolizumab + 5FU platinum chemotherapy will continue until disease progression, death or unacceptable toxicity.</recruitment_details>
      <pre_assignment_details>As of 27 Apr 2021, 116 participants were enrolled. One participant was incorrectly re-randomized into the study under a new participant ID. This participant only contributed once to the analyses, under one participant ID in the started population table. An additional participant was randomized after the data cut off and did not receive feladilimab/placebo. This participant is not included in the Started population. Safety data collection is ongoing and will be updated at the End of Study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
          <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
        </group>
        <group group_id="P2">
          <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
          <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Modified Intent-to-Treat (mITT) Population</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>In Follow-Up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>On Study Treatment (pembrolizumab) All participants discontinued feladilimab/placebo</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
          <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
        </group>
        <group group_id="B2">
          <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
          <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="57"/>
            <count group_id="B2" value="59"/>
            <count group_id="B3" value="116"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>18-64 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65-84 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian - Central/South Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - Japanese Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - White/Caucasian/European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS) in mITT Population</title>
        <description>OS was defined as the time from the date of randomization to the date of death due to any cause. Kaplan-Meier estimate for the median OS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>mITT population: All randomized participants whether or not randomized intervention was administered, excluding those who were first dosed or randomized after the date of DIL requesting immediate discontinuation of feladilimab /placebo. Participants were analyzed based on the study intervention to which the participant was randomized</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) in mITT Population</title>
          <description>OS was defined as the time from the date of randomization to the date of death due to any cause. Kaplan-Meier estimate for the median OS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
          <population>mITT population: All randomized participants whether or not randomized intervention was administered, excluding those who were first dosed or randomized after the date of DIL requesting immediate discontinuation of feladilimab /placebo. Participants were analyzed based on the study intervention to which the participant was randomized</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="5.1" upper_limit="NA">The median was not reached at the time of data cut off. The upper limit of the 95% CI was not calculable from the available data at the time of data cut off.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="4.1" upper_limit="NA">The median was not reached at the time of data cut off. The upper limit of the 95% CI was not calculable from the available data at the time of data cut off.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20 vs. CPS &lt;1) and Human Papilloma Virus (HPV) status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Other</non_inferiority_desc>
            <p_value>0.740</p_value>
            <p_value_desc>Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20 vs. CPS &lt;1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).</p_value_desc>
            <method>Stratified Cox proportional hazard model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>2.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.20</ci_lower_limit>
            <ci_upper_limit>23.87</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>OS in Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Population</title>
        <description>OS was defined as the time from the date of randomization until the date of death due to any cause. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median OS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in mITT population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>OS in Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Population</title>
          <description>OS was defined as the time from the date of randomization until the date of death due to any cause. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median OS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in mITT population are presented.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="5.1" upper_limit="NA">The median was not reached at the time of data cut off. The upper limit of the 95% CI was not calculable from the available data at the time of data cut off.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="4.1" upper_limit="NA">The median was not reached at the time of data cut off. The upper limit of the 95% CI was not calculable from the available data at the time of data cut off.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥ 20 vs 1≤ CPS&lt;20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Other</non_inferiority_desc>
            <p_value>0.740</p_value>
            <p_value_desc>Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).</p_value_desc>
            <method>Stratified Cox proportional hazard model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>2.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.20</ci_lower_limit>
            <ci_upper_limit>23.87</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 in mITT Population</title>
        <description>PFS per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 was defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>All participants in the mITT population were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 in mITT Population</title>
          <description>PFS per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 was defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
          <population>All participants in the mITT population were analyzed</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="3.7" upper_limit="5.5"/>
                    <measurement group_id="O2" value="4.7" lower_limit="4.7" upper_limit="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20 vs. CPS &lt;1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Other</non_inferiority_desc>
            <p_value>0.284</p_value>
            <p_value_desc>Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20 vs. CPS &lt;1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).</p_value_desc>
            <method>Stratified Cox proportional hazard model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.20</ci_lower_limit>
            <ci_upper_limit>2.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PFS Per RECIST v1.1 in the PD-L1 CPS ≥1 Population</title>
        <description>PFS per RECIST v1.1 was defined as the time from the date of randomization until the date of disease progression or death due to any cause, whichever occurs first. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in mITT population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>PFS Per RECIST v1.1 in the PD-L1 CPS ≥1 Population</title>
          <description>PFS per RECIST v1.1 was defined as the time from the date of randomization until the date of disease progression or death due to any cause, whichever occurs first. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in mITT population are presented.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="3.7" upper_limit="5.5"/>
                    <measurement group_id="O2" value="4.7" lower_limit="4.7" upper_limit="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS&lt;20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Other</non_inferiority_desc>
            <p_value>0.284</p_value>
            <p_value_desc>Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).</p_value_desc>
            <method>Stratified Cox proportional hazard model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.20</ci_lower_limit>
            <ci_upper_limit>2.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Milestone OS Rate at 12, 24 and 36 Months in mITT Population</title>
        <description>Milestone OS rate at 12, 24, and 36 months was not evaluated.</description>
        <time_frame>Months 12, 24 and 36</time_frame>
        <population>mITT population. All participants were on study for &lt;12 months. The maximum duration of follow-up was approximately 7 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Milestone OS Rate at 12, 24 and 36 Months in mITT Population</title>
          <description>Milestone OS rate at 12, 24, and 36 months was not evaluated.</description>
          <population>mITT population. All participants were on study for &lt;12 months. The maximum duration of follow-up was approximately 7 months.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Milestone OS Rate at 12, 24 and 36 Months in PD-L1 CPS ≥1 Population</title>
        <description>Milestone OS rate at 12, 24, and 36 months was not evaluated. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
        <time_frame>Months 12, 24 and 36</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in mITT population were to be presented. All participants were on study for &lt;12 months. The maximum duration of follow-up was approximately 7 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Milestone OS Rate at 12, 24 and 36 Months in PD-L1 CPS ≥1 Population</title>
          <description>Milestone OS rate at 12, 24, and 36 months was not evaluated. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in mITT population were to be presented. All participants were on study for &lt;12 months. The maximum duration of follow-up was approximately 7 months.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR) Per RECIST v1.1 in mITT Population</title>
        <description>ORR per RECIST v1.1 was defined as the proportion of the participants who have a complete response (CR) or partial response (PR) as the best overall response per RECIST v1.1 based upon investigator assessment. As a randomized double-blind study in which primary endpoints are OS and PFS, the confirmation of CR and PR was not required. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>All participants in the mITT population were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR) Per RECIST v1.1 in mITT Population</title>
          <description>ORR per RECIST v1.1 was defined as the proportion of the participants who have a complete response (CR) or partial response (PR) as the best overall response per RECIST v1.1 based upon investigator assessment. As a randomized double-blind study in which primary endpoints are OS and PFS, the confirmation of CR and PR was not required. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted.</description>
          <population>All participants in the mITT population were analyzed</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="9.6" upper_limit="32.5"/>
                    <measurement group_id="O2" value="23.6" lower_limit="13.2" upper_limit="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The comparison between treatment groups was based on the stratified Miettinen &amp; Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20 vs. CPS &lt;1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>-4.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.8</ci_lower_limit>
            <ci_upper_limit>11.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ORR Per RECIST v1.1 in PD-L1 CPS ≥1 Population</title>
        <description>ORR per RECIST v1.1 was defined as the proportion of the participants who have a complete response (CR) or partial response (PR) as the best overall response per RECIST v1.1 based upon investigator assessment. As a randomized double-blind study in which primary endpoints are OS and PFS, the confirmation of CR and PR was not required. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in mITT population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>ORR Per RECIST v1.1 in PD-L1 CPS ≥1 Population</title>
          <description>ORR per RECIST v1.1 was defined as the proportion of the participants who have a complete response (CR) or partial response (PR) as the best overall response per RECIST v1.1 based upon investigator assessment. As a randomized double-blind study in which primary endpoints are OS and PFS, the confirmation of CR and PR was not required. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in mITT population are presented.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4" lower_limit="8.8" upper_limit="32.0"/>
                    <measurement group_id="O2" value="23.1" lower_limit="12.5" upper_limit="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The comparison between treatment groups was based on the stratified Miettinen &amp; Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS≥20 vs 1≤CPS&lt;20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>-5.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.4</ci_lower_limit>
            <ci_upper_limit>11.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR) Per RECIST v1.1 in mITT Population</title>
        <description>DCR per RECIST v1.1 based upon investigator assessment, was defined as the percentage of participants with a best overall response of CR or PR at any time plus stable disease (SD) meeting the minimum time of 15 weeks. A status of SD≥15 weeks will be assigned if the follow-up disease assessment has met the SD criteria at least once after the date of randomization at a minimum of 14 weeks (98 days) considering a one-week visit window. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>All participants in the mITT population were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR) Per RECIST v1.1 in mITT Population</title>
          <description>DCR per RECIST v1.1 based upon investigator assessment, was defined as the percentage of participants with a best overall response of CR or PR at any time plus stable disease (SD) meeting the minimum time of 15 weeks. A status of SD≥15 weeks will be assigned if the follow-up disease assessment has met the SD criteria at least once after the date of randomization at a minimum of 14 weeks (98 days) considering a one-week visit window. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted.</description>
          <population>All participants in the mITT population were analyzed</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.7" lower_limit="20.3" upper_limit="47.1"/>
                    <measurement group_id="O2" value="36.4" lower_limit="23.8" upper_limit="50.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The comparison between treatment groups was based on the stratified Miettinen &amp; Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20 vs. CPS &lt;1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>-4.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.2</ci_lower_limit>
            <ci_upper_limit>13.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DCR Per RECIST v1.1 in PD-L1 CPS ≥1 Population</title>
        <description>DCR per RECIST v1.1 based upon investigator assessment, was defined as the percentage of participants with a best overall response of CR or PR at any time plus stable disease (SD) meeting the minimum time of 15 weeks. A status of SD≥15 weeks will be assigned if the follow-up disease assessment has met the SD criteria at least once after the date of randomization at a minimum of 14 weeks (98 days) considering a one-week visit window. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in mITT population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>DCR Per RECIST v1.1 in PD-L1 CPS ≥1 Population</title>
          <description>DCR per RECIST v1.1 based upon investigator assessment, was defined as the percentage of participants with a best overall response of CR or PR at any time plus stable disease (SD) meeting the minimum time of 15 weeks. A status of SD≥15 weeks will be assigned if the follow-up disease assessment has met the SD criteria at least once after the date of randomization at a minimum of 14 weeks (98 days) considering a one-week visit window. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in mITT population are presented.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6" lower_limit="18.3" upper_limit="45.4"/>
                    <measurement group_id="O2" value="34.6" lower_limit="22.0" upper_limit="49.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The comparison between treatment groups was based on the stratified Miettinen &amp; Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>-5.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.8</ci_lower_limit>
            <ci_upper_limit>13.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DoR) Per RECIST v1.1 in mITT Population</title>
        <description>DoR per RECIST v1.1 is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. Kaplan-Meier estimate for the median DoR is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with a best overall response of CR or PR in mITT population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DoR) Per RECIST v1.1 in mITT Population</title>
          <description>DoR per RECIST v1.1 is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. Kaplan-Meier estimate for the median DoR is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
          <population>Data for participants with a best overall response of CR or PR in mITT population are presented.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">The median was not reached at the time of primary completion date. The upper and lower limit of the 95% CI was not calculable from the available data at the time of data cut off.</measurement>
                    <measurement group_id="O2" value="2.8" lower_limit="1.2" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DoR Per RECIST v1.1 in PD-L1 CPS ≥1 Population</title>
        <description>DoR per RECIST v1.1 is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. Kaplan-Meier estimate for the median DoR is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with a best overall response of CR or PR in mITT population with PD-L1 CPS ≥1 are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>DoR Per RECIST v1.1 in PD-L1 CPS ≥1 Population</title>
          <description>DoR per RECIST v1.1 is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. Kaplan-Meier estimate for the median DoR is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
          <population>Data for participants with a best overall response of CR or PR in mITT population with PD-L1 CPS ≥1 are presented.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">The median was not reached at the time of primary completion date. The upper and lower limit of the 95% CI was not calculable from the available data at the time of data cut off.</measurement>
                    <measurement group_id="O2" value="2.8" lower_limit="1.4" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) in Safety Population</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Safety Population: All randomized participants who took at least 1 dose of study intervention. Participants were analyzed according to the actual study intervention received.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) in Safety Population</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention</description>
          <population>Safety Population: All randomized participants who took at least 1 dose of study intervention. Participants were analyzed according to the actual study intervention received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs) in Safety Population</title>
        <description>SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other situations according to medical or scientific judgement.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>All participants in the safety population were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs) in Safety Population</title>
          <description>SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other situations according to medical or scientific judgement.</description>
          <population>All participants in the safety population were analyzed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events of Special Interest (AESI) in Safety Population</title>
        <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>All participants in the safety population were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events of Special Interest (AESI) in Safety Population</title>
          <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated.</description>
          <population>All participants in the safety population were analyzed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With AEs in PD-L1 CPS ≥1 Population</title>
        <description>Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With AEs in PD-L1 CPS ≥1 Population</title>
          <description>Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With SAEs in PD-L1 CPS ≥1 Population</title>
        <description>SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other situations according to medical or scientific judgement. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With SAEs in PD-L1 CPS ≥1 Population</title>
          <description>SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other situations according to medical or scientific judgement. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With AESIs in PD-L1 CPS ≥1 Population</title>
        <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With AESIs in PD-L1 CPS ≥1 Population</title>
          <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of AEs in Safety Population</title>
        <description>An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity for each AE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>All participants in the safety population were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of AEs in Safety Population</title>
          <description>An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity for each AE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity.</description>
          <population>All participants in the safety population were analyzed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of SAEs in Safety Population</title>
        <description>A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. Severity for each SAE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing SAEs of Grade &gt;= 3 have been presented.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>All participants in the safety population were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of SAEs in Safety Population</title>
          <description>A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. Severity for each SAE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing SAEs of Grade &gt;= 3 have been presented.</description>
          <population>All participants in the safety population were analyzed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of AESIs in Safety Population</title>
        <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. Severity of each AESI was reported during the study and was assigned a grade according to the NCI-CTCAE. AESIs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE. Data of participants experiencing AESIs of Grade &gt;= 3 have been presented.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>All participants in the safety population were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of AESIs in Safety Population</title>
          <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. Severity of each AESI was reported during the study and was assigned a grade according to the NCI-CTCAE. AESIs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE. Data of participants experiencing AESIs of Grade &gt;= 3 have been presented.</description>
          <population>All participants in the safety population were analyzed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of AEs in PD-L1 CPS ≥1 Population</title>
        <description>An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity for each AE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing AEs of Grade &gt;= 3 have been presented. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of AEs in PD-L1 CPS ≥1 Population</title>
          <description>An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity for each AE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing AEs of Grade &gt;= 3 have been presented. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of SAEs in PD-L1 CPS ≥1 Population</title>
        <description>A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. Severity for each SAE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing SAEs of Grade &gt;= 3 have been presented. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of SAEs in PD-L1 CPS ≥1 Population</title>
          <description>A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. Severity for each SAE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing SAEs of Grade &gt;= 3 have been presented. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of AESI in PD-L1 CPS ≥1 Population</title>
        <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. Severity of each AESI was reported during the study and was assigned a grade according to the NCI-CTCAE. AESIs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE. Data of participants experiencing AESIs of Grade &gt;= 3 have been presented.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of AESI in PD-L1 CPS ≥1 Population</title>
          <description>AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. Severity of each AESI was reported during the study and was assigned a grade according to the NCI-CTCAE. AESIs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE. Data of participants experiencing AESIs of Grade &gt;= 3 have been presented.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Dose Modifications in Safety Population</title>
        <description>Number of participants with dose modifications (including dose interruptions, dose delays, dose reductions and treatment discontinuations) were reported by each interventional component.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>All participants in the safety population were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Dose Modifications in Safety Population</title>
          <description>Number of participants with dose modifications (including dose interruptions, dose delays, dose reductions and treatment discontinuations) were reported by each interventional component.</description>
          <population>All participants in the safety population were analyzed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose interruption per component - feladilimab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="NA">Participants in this treatment arm were not dosed with feladilimab</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose interruption per component - placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Participants in this treatment arm were not dosed with placebo</measurement>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose interruption per component - pembrolizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose interruption per component - carboplatin/cisplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose interruption per component - fuorouracil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose delays per component - feladilimab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="NA">Participants in this treatment arm were not dosed with feladilimab</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose delays per component - placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Participants in this treatment arm were not dosed with placebo</measurement>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose delays per component - pembrolizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose delays per component - cisplatin/carboplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose delays per component - fluorouracil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reduction per component - feladilimab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Dose reductions were not permitted for feladilimab</measurement>
                    <measurement group_id="O2" value="NA">Participants in this treatment arm were not dosed with feladilimab</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reduction per component - placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Participants in this treatment arm were not dosed with placebo</measurement>
                    <measurement group_id="O2" value="NA">Dose reductions were not permitted for placebo</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reduction per component - pembrolizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Dose reductions were not permitted for pembrolizumab</measurement>
                    <measurement group_id="O2" value="NA">Dose reductions were not permitted for pembrolizumab</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reduction per component - carboplatin/cisplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reduction per component - fluorouracil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment discontinuation per component - feladilimab/placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment discontinuation per component - pembrolizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment discontinuation per component - carboplatin/cisplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment discontinuation per component - fluorouracil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Dose Modifications in PD-L1 CPS ≥1 Population</title>
        <description>Number of participants with dose modifications (including dose interruptions, dose delays, dose reductions and treatment discontinuations) were reported by each interventional component. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Dose Modifications in PD-L1 CPS ≥1 Population</title>
          <description>Number of participants with dose modifications (including dose interruptions, dose delays, dose reductions and treatment discontinuations) were reported by each interventional component. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in the safety population are presented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose Interruptions per component- feladilimab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="NA">Participants in this treatment arm were not dosed with feladilimab</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Interruptions per component- placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Participants in this treatment arm were not dosed with placebo</measurement>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Interruptions per component- pembrolizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Interruptions per component- carboplatin/cisplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Interruptions per component- fluorouracil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Delays per component - feladilimab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="NA">Participants in this treatment arm were not dosed with feladilimab</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Delays per component - placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Participants in this treatment arm were not dosed with placebo</measurement>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Delays per component - pembrolizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Delays per component - carboplatin/cisplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Delays per component - fluorouracil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reductions per component - feladilimab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Dose reductions were not permitted for feladilimab</measurement>
                    <measurement group_id="O2" value="NA">Participants in this treatment arm were not dosed with feladilimab</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reductions per component - placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Participants in this treatment arm were not dosed with placebo</measurement>
                    <measurement group_id="O2" value="NA">Dose reductions were not permitted for placebo</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reductions per component - pembrolizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Dose reductions were not permitted for pembrolizumab</measurement>
                    <measurement group_id="O2" value="NA">Dose reductions were not permitted for pembrolizumab</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reductions per component - carboplatin/cisplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reductions per component - fluorouracil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Discontinuations per component - feladilimab/placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Discontinuations per component - pembrolizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Discontinuations per component - carboplatin/cisplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Discontinuations per component - fluorouracil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Deterioration (TTD) in Pain in mITT Population</title>
        <description>TTD in pain is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the European Organization for Research and Treatment of Cancer Item Library(EORTC IL51) Questionnaire pain domain, i.e. an increase from baseline of at least 8.33 observed at all subsequent non-missing visits. The EORTC Quality of Life Questionnaire 35-Item Head and Neck Module (QLQ-H&amp;N35) is a head and neck specific module with multi-item scales. The mouth pain, swallowing, speech problems, opening mouth, coughing, feeding tube, and trouble with social eating domains were administered and referred to as the EORTC IL51. The questionnaire scores for each scale and single-item measure are averaged and transformed linearly to present a score ranging from 0-100. A high score represents a high/healthy level of functioning. Kaplan-Meier estimate for the median TTD is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>All participants in the mITT population were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Deterioration (TTD) in Pain in mITT Population</title>
          <description>TTD in pain is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the European Organization for Research and Treatment of Cancer Item Library(EORTC IL51) Questionnaire pain domain, i.e. an increase from baseline of at least 8.33 observed at all subsequent non-missing visits. The EORTC Quality of Life Questionnaire 35-Item Head and Neck Module (QLQ-H&amp;N35) is a head and neck specific module with multi-item scales. The mouth pain, swallowing, speech problems, opening mouth, coughing, feeding tube, and trouble with social eating domains were administered and referred to as the EORTC IL51. The questionnaire scores for each scale and single-item measure are averaged and transformed linearly to present a score ranging from 0-100. A high score represents a high/healthy level of functioning. Kaplan-Meier estimate for the median TTD is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.</description>
          <population>All participants in the mITT population were analyzed</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" lower_limit="2.1" upper_limit="4.4"/>
                    <measurement group_id="O2" value="2.8" lower_limit="1.4" upper_limit="NA">The upper limit of the 95% CI was not calculable from the available data at the time of data cut off.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20 vs. CPS &lt;1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Other</non_inferiority_desc>
            <p_value>0.329</p_value>
            <p_value_desc>Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20 vs. CPS &lt;1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).</p_value_desc>
            <method>Stratified Cox proportional hazard model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.42</ci_lower_limit>
            <ci_upper_limit>1.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TTD in Pain in PD-L1 CPS ≥1 Population</title>
        <description>TTD in pain is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the EORTC IL51 pain domain, i.e. an increase from baseline of at least 8.33 observed at all subsequent non-missing visits. The EORTC QLQ-H&amp;N35 is a head and neck specific module with multi-item scales. The mouth pain, swallowing, speech problems, opening mouth, coughing, feeding tube, and trouble with social eating domains were administered and referred to as the EORTC IL51. The questionnaire scores for each scale and single-item measure are averaged and transformed linearly to present a score ranging from 0-100. A high score represents a high/healthy level of functioning. Kaplan-Meier estimate for the median TTD is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells to the total number of viable tumor cells.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in the mITT population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>TTD in Pain in PD-L1 CPS ≥1 Population</title>
          <description>TTD in pain is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the EORTC IL51 pain domain, i.e. an increase from baseline of at least 8.33 observed at all subsequent non-missing visits. The EORTC QLQ-H&amp;N35 is a head and neck specific module with multi-item scales. The mouth pain, swallowing, speech problems, opening mouth, coughing, feeding tube, and trouble with social eating domains were administered and referred to as the EORTC IL51. The questionnaire scores for each scale and single-item measure are averaged and transformed linearly to present a score ranging from 0-100. A high score represents a high/healthy level of functioning. Kaplan-Meier estimate for the median TTD is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells to the total number of viable tumor cells.</description>
          <population>Data for participants with PD-L1 CPS ≥1 in the mITT population are presented.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="1.3" upper_limit="4.4"/>
                    <measurement group_id="O2" value="2.8" lower_limit="1.4" upper_limit="NA">The upper limit of the 95% CI was not calculable from the available data at the time of data cut off.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS&lt;20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Other</non_inferiority_desc>
            <p_value>0.302</p_value>
            <p_value_desc>Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).</p_value_desc>
            <method>Stratified Cox proportional hazard model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>1.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TTD in Physical Function in mITT Population</title>
        <description>TTD in physical function (PF) is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the PF T-score, i.e. a decrease from baseline of at least 2.4 observed at all subsequent non-missing visits, as measured by the Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS PF 8c).The PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It includes a 5-point scale with three sets of response options. Scores on the PROMIS PF 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning.</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>All participants in the mITT population were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>TTD in Physical Function in mITT Population</title>
          <description>TTD in physical function (PF) is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the PF T-score, i.e. a decrease from baseline of at least 2.4 observed at all subsequent non-missing visits, as measured by the Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS PF 8c).The PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It includes a 5-point scale with three sets of response options. Scores on the PROMIS PF 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning.</description>
          <population>All participants in the mITT population were analyzed</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="1.4" upper_limit="NA">The available data does not allow for the calculation of the upper limit of the 95% CI.</measurement>
                    <measurement group_id="O2" value="4.3" lower_limit="2.1" upper_limit="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20 vs. CPS &lt;1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Other</non_inferiority_desc>
            <p_value>0.472</p_value>
            <p_value_desc>Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20 vs. CPS &lt;1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).</p_value_desc>
            <method>Stratified Cox proportional hazard model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>2.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TTD in Physical Function in PD-L1 CPS ≥1 Population</title>
        <description>TTD in PF is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the PF T-score, i.e. a decrease from baseline of at least 2.4 observed at all subsequent non-missing visits, as measured by the PROMIS PF 8c.The PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It includes a 5-point scale with three sets of response options. Scores on the PROMIS PF 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells</description>
        <time_frame>Up to approximately 7 months</time_frame>
        <population>Data for participants with PD-L1 CPS ≥1 in the mITT population are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
            <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>TTD in Physical Function in PD-L1 CPS ≥1 Population</title>
          <description>TTD in PF is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the PF T-score, i.e. a decrease from baseline of at least 2.4 observed at all subsequent non-missing visits, as measured by the PROMIS PF 8c.The PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It includes a 5-point scale with three sets of response options. Scores on the PROMIS PF 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells</description>
          <population>Data for participants with PD-L1 CPS ≥1 in the mITT population are presented.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="2.1" upper_limit="NA">The available data does not allow for the calculation of the upper limit of the 95% CI.</measurement>
                    <measurement group_id="O2" value="4.3" lower_limit="2.1" upper_limit="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS&lt;20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Other</non_inferiority_desc>
            <p_value>0.335</p_value>
            <p_value_desc>Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS &lt;20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).</p_value_desc>
            <method>Stratified Cox proportional hazard model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>1.90</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All cause mortality, non-SAEs and SAEs were collected from Day 1 to Up to approximately 7 months.</time_frame>
      <desc>Six participants initially randomized to feladilimab + pembrolizumab + 5-FU-platinum chemotherapy arm who received first dose after the DIL date were re-assigned to placebo + pembrolizumab + 5-FU-platinum chemotherapy arm. 1 participant was initially randomized to feladilimab + pembrolizumab + 5-FU-platinum chemotherapy arm but was never dosed and was excluded from the safety population. Safety data for participants who continue to receive pembrolizumab would be updated after study completion.</desc>
      <group_list>
        <group group_id="E1">
          <title>Feladilimab + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
          <description>Participants were administered feladilimab (humanized anti- ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
        </group>
        <group group_id="E2">
          <title>Placebo + Pembrolizumab + 5-FU-platinum Chemotherapy</title>
          <description>Participants were administered placebo and pembrolizumab as an IV infusion along with 5 FU-platinum chemotherapy (cisplatin OR carboplatin) Q3W.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Tracheal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Hyperammonaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Hypochloraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical cord compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Embedded device</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="22" subjects_at_risk="50"/>
                <counts group_id="E2" events="23" subjects_affected="16" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E2" events="22" subjects_affected="14" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" events="12" subjects_affected="9" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="50"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" events="18" subjects_affected="13" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="25" subjects_affected="21" subjects_at_risk="50"/>
                <counts group_id="E2" events="28" subjects_affected="25" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="50"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" events="12" subjects_affected="8" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="50"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Data are reported following the interim analysis decision to stop further accrual into the study and discontinue feladilimab/placebo. The study primary completion analysis results should be interpreted with consideration of the immature data</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04428333
org study id: 209227
secondary id: 2019-003981-42
nct id: NCT04428333
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in
      combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab
      combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic
      (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase
      II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum
      chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in
      participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx
      or larynx.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This will be a randomized, parallel group treatment study with eligible participants receiving either GSK3359609 in combination with pembrolizumab and 5FU-platinum chemotherapy or placebo in combination with pembrolizumab and 5FU-platinum chemotherapy.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: This is a double blind study.
measure: Overall Survival (OS) in mITT Population
time frame: Up to approximately 7 months
description: OS was defined as the time from the date of randomization to the date of death due to any cause. Kaplan-Meier estimate for the median OS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
measure: OS in Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Population
time frame: Up to approximately 7 months
description: OS was defined as the time from the date of randomization until the date of death due to any cause. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median OS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
measure: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 in mITT Population
time frame: Up to approximately 7 months
description: PFS per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 was defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
measure: PFS Per RECIST v1.1 in the PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: PFS per RECIST v1.1 was defined as the time from the date of randomization until the date of disease progression or death due to any cause, whichever occurs first. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
measure: Milestone OS Rate at 12, 24 and 36 Months in mITT Population
time frame: Months 12, 24 and 36
description: Milestone OS rate at 12, 24, and 36 months was not evaluated.
measure: Milestone OS Rate at 12, 24 and 36 Months in PD-L1 CPS ≥1 Population
time frame: Months 12, 24 and 36
description: Milestone OS rate at 12, 24, and 36 months was not evaluated. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
measure: Overall Response Rate (ORR) Per RECIST v1.1 in mITT Population
time frame: Up to approximately 7 months
description: ORR per RECIST v1.1 was defined as the proportion of the participants who have a complete response (CR) or partial response (PR) as the best overall response per RECIST v1.1 based upon investigator assessment. As a randomized double-blind study in which primary endpoints are OS and PFS, the confirmation of CR and PR was not required. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted.
measure: ORR Per RECIST v1.1 in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: ORR per RECIST v1.1 was defined as the proportion of the participants who have a complete response (CR) or partial response (PR) as the best overall response per RECIST v1.1 based upon investigator assessment. As a randomized double-blind study in which primary endpoints are OS and PFS, the confirmation of CR and PR was not required. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
measure: Disease Control Rate (DCR) Per RECIST v1.1 in mITT Population
time frame: Up to approximately 7 months
description: DCR per RECIST v1.1 based upon investigator assessment, was defined as the percentage of participants with a best overall response of CR or PR at any time plus stable disease (SD) meeting the minimum time of 15 weeks. A status of SD≥15 weeks will be assigned if the follow-up disease assessment has met the SD criteria at least once after the date of randomization at a minimum of 14 weeks (98 days) considering a one-week visit window. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted.
measure: DCR Per RECIST v1.1 in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: DCR per RECIST v1.1 based upon investigator assessment, was defined as the percentage of participants with a best overall response of CR or PR at any time plus stable disease (SD) meeting the minimum time of 15 weeks. A status of SD≥15 weeks will be assigned if the follow-up disease assessment has met the SD criteria at least once after the date of randomization at a minimum of 14 weeks (98 days) considering a one-week visit window. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
measure: Duration of Response (DoR) Per RECIST v1.1 in mITT Population
time frame: Up to approximately 7 months
description: DoR per RECIST v1.1 is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. Kaplan-Meier estimate for the median DoR is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
measure: DoR Per RECIST v1.1 in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: DoR per RECIST v1.1 is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. Kaplan-Meier estimate for the median DoR is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
measure: Number of Participants With Adverse Events (AEs) in Safety Population
time frame: Up to approximately 7 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention
measure: Number of Participants With Serious Adverse Events (SAEs) in Safety Population
time frame: Up to approximately 7 months
description: SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other situations according to medical or scientific judgement.
measure: Number of Participants With Adverse Events of Special Interest (AESI) in Safety Population
time frame: Up to approximately 7 months
description: AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated.
measure: Number of Participants With AEs in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
measure: Number of Participants With SAEs in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other situations according to medical or scientific judgement. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
measure: Number of Participants With AESIs in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
measure: Severity of AEs in Safety Population
time frame: Up to approximately 7 months
description: An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity for each AE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity.
measure: Severity of SAEs in Safety Population
time frame: Up to approximately 7 months
description: A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. Severity for each SAE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing SAEs of Grade >= 3 have been presented.
measure: Severity of AESIs in Safety Population
time frame: Up to approximately 7 months
description: AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. Severity of each AESI was reported during the study and was assigned a grade according to the NCI-CTCAE. AESIs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE. Data of participants experiencing AESIs of Grade >= 3 have been presented.
measure: Severity of AEs in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity for each AE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing AEs of Grade >= 3 have been presented. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
measure: Severity of SAEs in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. Severity for each SAE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing SAEs of Grade >= 3 have been presented. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
measure: Severity of AESI in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. Severity of each AESI was reported during the study and was assigned a grade according to the NCI-CTCAE. AESIs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE. Data of participants experiencing AESIs of Grade >= 3 have been presented.
measure: Number of Participants With Dose Modifications in Safety Population
time frame: Up to approximately 7 months
description: Number of participants with dose modifications (including dose interruptions, dose delays, dose reductions and treatment discontinuations) were reported by each interventional component.
measure: Number of Participants With Dose Modifications in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: Number of participants with dose modifications (including dose interruptions, dose delays, dose reductions and treatment discontinuations) were reported by each interventional component. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
measure: Time to Deterioration (TTD) in Pain in mITT Population
time frame: Up to approximately 7 months
description: TTD in pain is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the European Organization for Research and Treatment of Cancer Item Library(EORTC IL51) Questionnaire pain domain, i.e. an increase from baseline of at least 8.33 observed at all subsequent non-missing visits. The EORTC Quality of Life Questionnaire 35-Item Head and Neck Module (QLQ-H&N35) is a head and neck specific module with multi-item scales. The mouth pain, swallowing, speech problems, opening mouth, coughing, feeding tube, and trouble with social eating domains were administered and referred to as the EORTC IL51. The questionnaire scores for each scale and single-item measure are averaged and transformed linearly to present a score ranging from 0-100. A high score represents a high/healthy level of functioning. Kaplan-Meier estimate for the median TTD is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
measure: TTD in Pain in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: TTD in pain is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the EORTC IL51 pain domain, i.e. an increase from baseline of at least 8.33 observed at all subsequent non-missing visits. The EORTC QLQ-H&N35 is a head and neck specific module with multi-item scales. The mouth pain, swallowing, speech problems, opening mouth, coughing, feeding tube, and trouble with social eating domains were administered and referred to as the EORTC IL51. The questionnaire scores for each scale and single-item measure are averaged and transformed linearly to present a score ranging from 0-100. A high score represents a high/healthy level of functioning. Kaplan-Meier estimate for the median TTD is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells to the total number of viable tumor cells.
measure: TTD in Physical Function in mITT Population
time frame: Up to approximately 7 months
description: TTD in physical function (PF) is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the PF T-score, i.e. a decrease from baseline of at least 2.4 observed at all subsequent non-missing visits, as measured by the Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS PF 8c).The PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It includes a 5-point scale with three sets of response options. Scores on the PROMIS PF 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning.
measure: TTD in Physical Function in PD-L1 CPS ≥1 Population
time frame: Up to approximately 7 months
description: TTD in PF is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the PF T-score, i.e. a decrease from baseline of at least 2.4 observed at all subsequent non-missing visits, as measured by the PROMIS PF 8c.The PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It includes a 5-point scale with three sets of response options. Scores on the PROMIS PF 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells
arm group label: Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapy
arm group type: Experimental
arm group label: Placebo + Pembrolizumab + 5-FU-platinum chemotherapy
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Feladilimab
description: Humanized anti-inducible T cell co-stimulatory receptor (ICOS) immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
arm group label: Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapy
intervention type: Drug
intervention name: Pembrolizumab
description: Humanized anti- programmed cell death receptor1 (anti-PD-1) IgG4 mAb
arm group label: Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapy
arm group label: Placebo + Pembrolizumab + 5-FU-platinum chemotherapy
intervention type: Drug
intervention name: Placebo
description: Sterile normal saline
arm group label: Placebo + Pembrolizumab + 5-FU-platinum chemotherapy
intervention type: Drug
intervention name: Platinum based chemotherapy
description: Cisplatin/carboplatin
arm group label: Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapy
arm group label: Placebo + Pembrolizumab + 5-FU-platinum chemotherapy
intervention type: Drug
intervention name: Fluorouracil (5FU)
description: 5-fluorouracil
arm group label: Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapy
arm group label: Placebo + Pembrolizumab + 5-FU-platinum chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Argentina
country: Australia
country: Belgium
country: Brazil
country: Canada
country: Denmark
country: France
country: Germany
country: Ireland
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Romania
country: Russian Federation
country: Spain
country: Sweden
country: United Kingdom
country: United States
country: China
country: Taiwan
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Head and Neck Neoplasms
mesh term: Pembrolizumab
mesh term: Fluorouracil
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: http://clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Data are reported following the interim analysis decision to stop further accrual into the study and discontinue feladilimab/placebo. The study primary completion analysis results should be interpreted with consideration of the immature data
point of contact: 