<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/NCT03019588</url>
  </required_header>
  <id_info>
    <org_study_id>3475-063</org_study_id>
    <secondary_id>MK-3475-063</secondary_id>
    <nct_id>NCT03019588</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063)</brief_title>
  <official_title>A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will compare the efficacy and safety of treatment with pembrolizumab (MK-3475)&#xD;
      versus paclitaxel in Asian, programmed death-ligand 1 (PD-L1) positive participants with&#xD;
      advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after&#xD;
      failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent.&#xD;
&#xD;
      The primary study hypotheses are that pembrolizumab prolongs Overall Survival (OS) compared&#xD;
      to paclitaxel and that pembrolizumab prolongs Progression-free Survival (PFS) per Response&#xD;
      Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by blinded central&#xD;
      radiologists' review compared to paclitaxel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Once the participant has achieved the study objective or the study has ended, the participant&#xD;
      will be discontinued from the study and may be enrolled in an extension study to continue&#xD;
      protocol-defined assessments and treatment. Enrollment in the extension study will be&#xD;
      conditional on participant consent. Treatment with pembrolizumab or paclitaxel will continue&#xD;
      until documented disease progression, unacceptable adverse event(s), intercurrent illness&#xD;
      that prevents further administration of treatment, investigator's decision to discontinue the&#xD;
      participant, participant withdraws consent, pregnancy of the participant, participant&#xD;
      receives 35 administrations (approximately 2 years) of pembrolizumab, or administrative&#xD;
      reasons requiring cessation of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business Reasons&#xD;
  </why_stopped>
  <start_date type="Actual">February 16, 2017</start_date>
  <completion_date type="Actual">June 29, 2021</completion_date>
  <primary_completion_date type="Actual">June 29, 2021</primary_completion_date>
  <phase>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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 50 months</time_frame>
    <description>OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</measure>
    <time_frame>Up to approximately 50 months</time_frame>
    <description>PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. PFS as assessed by blinded independent central review will be presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) Per RECIST 1.1</measure>
    <time_frame>Up to approximately 50 months</time_frame>
    <description>ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experience an Adverse Event (AE)</measure>
    <time_frame>Up to approximately 50 months</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinue Study Treatment Due to an AE</measure>
    <time_frame>Up to approximately 25 months</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Gastric Neoplasms</condition>
  <condition>Gastroesophageal Junction Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paclitaxel 80 mg/m^2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Pembrolizumab 200 mg</arm_group_label>
    <other_name>MK-3475</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Paclitaxel 80 mg/m^2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has histologically or cytologically-confirmed diagnosis of gastric or GEJ&#xD;
             adenocarcinoma.&#xD;
&#xD;
          -  Has metastatic disease or locally advanced, unresectable disease.&#xD;
&#xD;
          -  Has measurable disease as defined by RECIST 1.1 as determined by investigator.&#xD;
&#xD;
          -  Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)&#xD;
             Performance Scale within 3 days prior to the first dose of study treatment.&#xD;
&#xD;
          -  Has experienced documented objective radiographic or clinical disease progression&#xD;
             during or after first-line therapy containing any platinum/fluoropyrimidine doublet.&#xD;
&#xD;
          -  Is willing to provide tissue for PD-L1 biomarker analysis.&#xD;
&#xD;
          -  Has PD-L1 positive tumor (based on analysis of sample provided to core lab).&#xD;
&#xD;
          -  Female participants of childbearing potential must be willing to use 2 methods of&#xD;
             birth control or be surgically sterile, or abstain from heterosexual activity for the&#xD;
             course of the study through 120 days after the last dose of study treatment for the&#xD;
             pembrolizumab arm and through 180 days after the last dose of study treatment for the&#xD;
             paclitaxel arm.&#xD;
&#xD;
          -  Male participants should agree to use an adequate method of contraception starting&#xD;
             with the first dose of study therapy through 120 days after the last dose of study&#xD;
             treatment for the pembrolizumab arm and through 180 days after the last dose of study&#xD;
             treatment for the paclitaxel arm.&#xD;
&#xD;
          -  Demonstrates adequate organ function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is currently participating and receiving study therapy or has participated in a study&#xD;
             of an investigational agent and received study therapy or used an investigation device&#xD;
             within 4 weeks of the first dose of trial treatment.&#xD;
&#xD;
          -  Has squamous cell or undifferentiated gastric cancer.&#xD;
&#xD;
          -  Has active autoimmune disease that has required systemic treatment in past 2 years.&#xD;
&#xD;
          -  Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the&#xD;
             first dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at&#xD;
             Baseline) from AEs due to agents administered more than 4 weeks earlier.&#xD;
&#xD;
          -  Has had prior chemotherapy, targeted small molecule therapy, radiation therapy, or any&#xD;
             other agents used as systemic treatment for cancer, within 2 weeks prior to the first&#xD;
             dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at Baseline) from&#xD;
             AEs due to a previously administered agent.&#xD;
&#xD;
          -  Has a known additional malignancy that is progressing or has required active treatment&#xD;
             within the past 5 years. Exceptions include basal cell carcinoma of the skin, squamous&#xD;
             cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially&#xD;
             curative therapy.&#xD;
&#xD;
          -  Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis.&#xD;
&#xD;
          -  Has a history of (non-infectious) pneumonitis that required steroids or current&#xD;
             pneumonitis.&#xD;
&#xD;
          -  Has an active infection requiring systemic therapy.&#xD;
&#xD;
          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the study, starting with the screening visit through 120 days&#xD;
             after the last dose of study treatment for the pembrolizumab arm and through 180 days&#xD;
             after the last dose of study treatment for the paclitaxel arm.&#xD;
&#xD;
          -  Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1),&#xD;
             anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or&#xD;
             co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4&#xD;
             [CTLA-4], OX-40, CD137).&#xD;
&#xD;
          -  Has a known history of Human Immunodeficiency Virus (HIV) infection.&#xD;
&#xD;
          -  Has known active Hepatitis B or C virus infection.&#xD;
&#xD;
          -  Has received a live vaccine within 30 days of planned start of study treatment.&#xD;
&#xD;
          -  Has known allergy or hypersensitivity to paclitaxel or any components used in the&#xD;
             paclitaxel preparation or other contraindication for taxane therapy.&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Cancer Hospital ( Site 0022)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fuzhou General Hospital of Nanjing Military Command ( Site 0023)</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Changzhou ( Site 0024)</name>
      <address>
        <city>Changzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing 81 PLA Hospital, Dept. of Oncology ( Site 0001)</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Province Cancer Hospital, Department of Chemotherapy ( Site 0002)</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tangdu Hospital ( Site 0030)</name>
      <address>
        <city>XI An</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0014)</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>301 Hospital ( Site 0008)</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>307 Hospital of PLA, Dept. of Oncology ( Site 0006)</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital ( Site 0011)</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central -South University ( Site 0021)</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Sun Sun Shaw Hosp, Zhejiang Univ,Oncology dept. ( Site 0016)</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhejiang University ( Site 0004)</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital ( Site 0020)</name>
      <address>
        <city>Harbin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anhui Provincial Hospital ( Site 0017)</name>
      <address>
        <city>Hefei</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Anhui Medical University ( Site 0012)</name>
      <address>
        <city>Hefei</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Anhui Medical University ( Site 0013)</name>
      <address>
        <city>Hefei</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Cancer Hospital ( Site 0003)</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0028)</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University ( Site 0018)</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai East Hospital ( Site 0033)</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Tenth People's Hospital ( Site 0026)</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital affiliated to Fudan University ( Site 0005)</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai First People's Hospital ( Site 0027)</name>
      <address>
        <city>Songjiang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 0025)</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical Center CHA University ( Site 0203)</name>
      <address>
        <city>Seongnam si</city>
        <state>Gyeonggi Do</state>
        <zip>4130</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center ( Site 0202)</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>4130</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, St. Vincent's Hospital ( Site 0201)</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggi-do</state>
        <zip>4130</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center ( Site 0204)</name>
      <address>
        <city>Seoul</city>
        <zip>4130</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kangbuk Samsung Hospital ( Site 0205)</name>
      <address>
        <city>Seoul</city>
        <zip>4130</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital Yonsei University Health System ( Site 0206)</name>
      <address>
        <city>Seoul</city>
        <zip>4130</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Malaya Medical Centre (UMMC) ( Site 0126)</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Wilayah Persekutuan</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation - Kaohsiung ( Site 0227)</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital. ( Site 0226)</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koo Foundation Sun Yat-Sen Cancer Center ( Site 0228)</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MacKay Memorial Hospital ( Site 0229)</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://keynoteclinicaltrials.com/</url>
    <description>Merck Oncology Clinical Trial Information</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <results_first_submitted>June 21, 2022</results_first_submitted>
  <results_first_submitted_qc>June 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 30, 2023</results_first_posted>
  <last_update_submitted>June 21, 2022</last_update_submitted>
  <last_update_submitted_qc>June 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Programmed Cell Death-1 (PD1, PD-1)</keyword>
  <keyword>Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)</keyword>
  <keyword>Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Pembrolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</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>April 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03019588/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>November 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03019588/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pembrolizumab 200 mg</title>
          <description>Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).</description>
        </group>
        <group group_id="P2">
          <title>Paclitaxel 80 mg/m^2</title>
          <description>Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pembrolizumab 200 mg</title>
          <description>Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).</description>
        </group>
        <group group_id="B2">
          <title>Paclitaxel 80 mg/m^2</title>
          <description>Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.</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="47"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="94"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.0" spread="10.4"/>
                    <measurement group_id="B2" value="59.0" spread="11.2"/>
                    <measurement group_id="B3" value="58.5" spread="10.8"/>
                  </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="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time to progression on first-line therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eastern Cooperative Oncology Group Performance Status (ECOG PS)</title>
          <description>ECOG PS is graded on a scale from 0 (best) to 5 (worst). 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2= ambulatory and capable of all selfcare but unable to carry out any work activities (up and about more than 50% of waking hours); 3= capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair; 5= dead.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>ECOG = 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG = 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.</description>
        <time_frame>Up to approximately 50 months</time_frame>
        <population>Analysis population includes all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 200 mg</title>
            <description>Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel 80 mg/m^2</title>
            <description>Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.</description>
          <population>Analysis population includes all randomized participants.</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="47"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" lower_limit="4.0" upper_limit="9.5"/>
                    <measurement group_id="O2" value="7.7" lower_limit="5.4" upper_limit="11.3"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2900</p_value>
            <method>Log Rank</method>
            <method_desc>One-sided p-value based on log-rank test stratified by time to progression on first line therapy (&lt; 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
            <estimate_desc>Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (&lt; 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</title>
        <description>PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. PFS as assessed by blinded independent central review will be presented.</description>
        <time_frame>Up to approximately 50 months</time_frame>
        <population>Analysis population includes all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 200 mg</title>
            <description>Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel 80 mg/m^2</title>
            <description>Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</title>
          <description>PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. PFS as assessed by blinded independent central review will be presented.</description>
          <population>Analysis population includes all randomized participants.</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="47"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="1.4" upper_limit="2.8"/>
                    <measurement group_id="O2" value="4.0" lower_limit="2.7" upper_limit="6.2"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9954</p_value>
            <method>Log Rank</method>
            <method_desc>One-sided p-value based on log-rank test stratified by time to progression on first line therapy (&lt; 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.14</ci_lower_limit>
            <ci_upper_limit>2.74</ci_upper_limit>
            <estimate_desc>Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (&lt; 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) Per RECIST 1.1</title>
        <description>ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1.</description>
        <time_frame>Up to approximately 50 months</time_frame>
        <population>Analysis population includes all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 200 mg</title>
            <description>Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel 80 mg/m^2</title>
            <description>Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) Per RECIST 1.1</title>
          <description>ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1.</description>
          <population>Analysis population includes all randomized participants.</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="47"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" lower_limit="4.8" upper_limit="25.7"/>
                    <measurement group_id="O2" value="19.1" lower_limit="9.1" upper_limit="33.3"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7884</p_value>
            <method>Z-test</method>
            <method_desc>One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % &gt; 0.</method_desc>
            <param_type>Difference in percentage</param_type>
            <param_value>-6.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.6</ci_lower_limit>
            <ci_upper_limit>9.3</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method stratified by time to progression on first line therapy (&lt; 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experience an Adverse Event (AE)</title>
        <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
        <time_frame>Up to approximately 50 months</time_frame>
        <population>Analysis population includes all randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 200 mg</title>
            <description>Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel 80 mg/m^2</title>
            <description>Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experience an Adverse Event (AE)</title>
          <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
          <population>Analysis population includes all randomized participants who received at least one dose of study treatment.</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="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinue Study Treatment Due to an AE</title>
        <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
        <time_frame>Up to approximately 25 months</time_frame>
        <population>Analysis population includes all randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 200 mg</title>
            <description>Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel 80 mg/m^2</title>
            <description>Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinue Study Treatment Due to an AE</title>
          <description>An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
          <population>Analysis population includes all randomized participants who received at least one dose of study treatment.</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="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 50 months</time_frame>
      <desc>All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms &quot;Neoplasm Progression&quot;, &quot;Malignant Neoplasm Progression&quot; and &quot;Disease Progression&quot; not related to the drug are excluded.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pembrolizumab 200 mg</title>
          <description>Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).</description>
        </group>
        <group group_id="E2">
          <title>Paclitaxel 80 mg/m^2</title>
          <description>Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</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="44" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="44"/>
              </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="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Thyroiditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </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="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </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="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.0</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="46" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="44"/>
              </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="21" subjects_affected="17" subjects_at_risk="47"/>
                <counts group_id="E2" events="26" subjects_affected="20" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Granulocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="17" subjects_affected="3" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="22" subjects_affected="4" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="19" subjects_affected="6" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="47"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="47"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="21" subjects_affected="8" subjects_at_risk="47"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="47"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="47"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="47"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="47"/>
                <counts group_id="E2" events="11" subjects_affected="7" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="55" subjects_affected="17" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="49" subjects_affected="13" subjects_at_risk="44"/>
              </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="47"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="47"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Hypoproteinaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="44"/>
              </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>The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme LLC</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT03019588
org study id: 3475-063
secondary id: MK-3475-063
nct id: NCT03019588
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study will compare the efficacy and safety of treatment with pembrolizumab (MK-3475)
      versus paclitaxel in Asian, programmed death-ligand 1 (PD-L1) positive participants with
      advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after
      failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent.

      The primary study hypotheses are that pembrolizumab prolongs Overall Survival (OS) compared
      to paclitaxel and that pembrolizumab prolongs Progression-free Survival (PFS) per Response
      Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by blinded central
      radiologists' review compared to paclitaxel.
Once the participant has achieved the study objective or the study has ended, the participant
      will be discontinued from the study and may be enrolled in an extension study to continue
      protocol-defined assessments and treatment. Enrollment in the extension study will be
      conditional on participant consent. Treatment with pembrolizumab or paclitaxel will continue
      until documented disease progression, unacceptable adverse event(s), intercurrent illness
      that prevents further administration of treatment, investigator's decision to discontinue the
      participant, participant withdraws consent, pregnancy of the participant, participant
      receives 35 administrations (approximately 2 years) of pembrolizumab, or administrative
      reasons requiring cessation of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS)
time frame: Up to approximately 50 months
description: OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
measure: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
time frame: Up to approximately 50 months
description: PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. PFS as assessed by blinded independent central review will be presented.
measure: Objective Response Rate (ORR) Per RECIST 1.1
time frame: Up to approximately 50 months
description: ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1.
measure: Number of Participants Who Experience an Adverse Event (AE)
time frame: Up to approximately 50 months
description: An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
time frame: Up to approximately 25 months
description: An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
arm group label: Pembrolizumab 200 mg
arm group type: Experimental
description: Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
arm group label: Paclitaxel 80 mg/m^2
arm group type: Active Comparator
description: Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
intervention type: Biological
intervention name: Pembrolizumab
description: IV infusion
arm group label: Pembrolizumab 200 mg
other name: MK-3475
intervention type: Drug
intervention name: Paclitaxel
description: IV infusion
arm group label: Paclitaxel 80 mg/m^2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
country: Korea, Republic of
country: Malaysia
country: Taiwan
url: http://keynoteclinicaltrials.com/
description: Merck Oncology Clinical Trial Information
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Esophageal Neoplasms
mesh term: Stomach Neoplasms
mesh term: Paclitaxel
mesh term: Pembrolizumab
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 