<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/NCT04489888</url>
  </required_header>
  <id_info>
    <org_study_id>3475-B10</org_study_id>
    <secondary_id>MK-3475-B10</secondary_id>
    <nct_id>NCT04489888</nct_id>
  </id_info>
  <brief_title>A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)</brief_title>
  <official_title>A Phase 4, Single-arm, Open-label Clinical Study of Pembrolizumab (MK-3475) to Evaluate the Efficacy and Safety of MK-3475 Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE B10).</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>No</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 goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with&#xD;
      carboplatin and paclitaxel as first line treatment in participants with recurrent/metastatic&#xD;
      head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested&#xD;
      in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 27, 2020</start_date>
  <completion_date type="Anticipated">July 25, 2024</completion_date>
  <primary_completion_date type="Actual">February 20, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Up to ~20 months</time_frame>
    <description>ORR is defined as the percentage of participants who have 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 of diameters) per Response Evaluation Criteria in Solid Tumors Update and Clarification 1.1 (RECIST 1.1) which has been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to ~47 months</time_frame>
    <description>For participants who demonstrate a confirmed Complete Response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. RECIST 1.1 has been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR as assessed by blinded independent central review based on RECIST 1.1 will be presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>Up to ~47 months</time_frame>
    <description>PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independent central review based on RECIST 1.1 will be presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to ~47 months</time_frame>
    <description>OS is defined as the time from first dose of study treatment to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Experience an Adverse Event (AE)</measure>
    <time_frame>Up to ~27 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience an AE will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Discontinue Study Treatment due to an AE</measure>
    <time_frame>Up to ~24 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Squamous Cell Carcinoma of Head and Neck</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab + Carboplatin + Paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab will be administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Carboplatin will be administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). At investigator's choice, paclitaxel will be administered via IV infusion at a dose of 100 mg/m^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to ~4 months) or at a dose of 175 mg/m^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle</description>
    <arm_group_label>Pembrolizumab + Carboplatin + Paclitaxel</arm_group_label>
    <other_name>MK-3475</other_name>
    <other_name>KEYTRUDA®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle</description>
    <arm_group_label>Pembrolizumab + Carboplatin + Paclitaxel</arm_group_label>
    <other_name>PARAPLATIN®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>At investigator's choice, paclitaxel 100 mg/m^2 IV infusion given on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each 21-day cycle</description>
    <arm_group_label>Pembrolizumab + Carboplatin + Paclitaxel</arm_group_label>
    <other_name>TAXOL®</other_name>
    <other_name>ONXAL®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has histologically or cytologically-confirmed diagnosis of R/M HNSCC that is&#xD;
             considered incurable by local therapies&#xD;
&#xD;
          -  Male participants refrain from donating sperm plus are abstinent from heterosexual&#xD;
             intercourse or agree to use contraception during the intervention period and for at&#xD;
             least 95 days after carboplatin/paclitaxel&#xD;
&#xD;
          -  Female participants are not pregnant or breastfeeding and are either not a woman of&#xD;
             child-bearing potential (WOCBP) or use a contraceptive method that is highly effective&#xD;
             or are abstinent from heterosexual intercourse during the intervention period and for&#xD;
             at least 120 days after pembrolizumab or 30 days after paclitaxel or 6 months after&#xD;
             carboplatin whichever occurs last, and agree not to donate or freeze eggs during this&#xD;
             period&#xD;
&#xD;
          -  Has adequate organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has disease that is suitable for local therapy administered with curative intent&#xD;
&#xD;
          -  Has a life expectancy of less than 3 months and/or has rapidly progressive disease&#xD;
&#xD;
          -  Has a diagnosed and/or treated additional malignancy within 5 years prior to&#xD;
             allocation with the exception of curatively treated basal cell carcinoma of the skin,&#xD;
             squamous cell carcinoma of the skin, curatively resected in situ cervical cancer and&#xD;
             curatively resected in situ breast cancer&#xD;
&#xD;
          -  Has received a live or live-attenuated vaccine within 30 days prior to the first dose&#xD;
             of study intervention&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy&#xD;
             or any other form of immunosuppressive therapy within 7 days prior to the first dose&#xD;
             of study intervention&#xD;
&#xD;
          -  Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis&#xD;
&#xD;
          -  Has a history of or current non-infectious pneumonitis/interstitial lung disease that&#xD;
             requires steroids&#xD;
&#xD;
          -  Has an active infection requiring systemic therapy&#xD;
&#xD;
          -  Has a known history of human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Has a known history of Hepatitis B or Hepatitis C virus infection&#xD;
&#xD;
          -  Has had an allogenic tissue/solid organ transplant&#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>Yale-New Haven Hospital-Yale Cancer Center ( Site 0265)</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helen F. Graham Cancer Center &amp; Research Institute ( Site 0214)</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist MD Anderson Cancer Center ( Site 0215)</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Health, Inc. ( Site 0216)</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regions Hospital ( Site 0227)</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine ( Site 0240)</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erie County Medical Center-Head &amp; Neck Surgery and Plastic &amp; Reconstructive Surgery ( Site 0268)</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262)</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novant Health Presbyterian ( Site 0261)</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novant Health Forsyth Medical Center ( Site 0266)</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center ( Site 0253)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Hospital - Asplundh Cancer Center ( Site 0229)</name>
      <address>
        <city>Willow Grove</city>
        <state>Pennsylvania</state>
        <zip>19090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Oncology ( Site 0231)</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University ( Site 0233)</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Provincial del Centenario ( Site 0304)</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico San Roque ( Site 0302)</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <zip>T4000IAK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1012AAR</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Respirar ( Site 0306)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1426ABP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Medico Especializado Alexander Fleming ( Site 0301)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1426ANZ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange Health Services ( Site 0106)</name>
      <address>
        <city>Orange</city>
        <state>New South Wales</state>
        <zip>2800</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Townsville Hospital ( Site 0105)</name>
      <address>
        <city>Douglas</city>
        <state>Queensland</state>
        <zip>4814</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gold Coast University Hospital ( Site 0103)</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincents Hospital Melbourne ( Site 0101)</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Regional Integrado de Oncologia ( Site 0403)</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceara</state>
        <zip>60336-232</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CETUS Hospital Dia Oncologia ( Site 0400)</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30110-022</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liga Norte Riograndense Contra o Cancer ( Site 0404)</name>
      <address>
        <city>Natal</city>
        <state>Rio Grande Do Norte</state>
        <zip>59075-740</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0406)</name>
      <address>
        <city>Ijui</city>
        <state>Rio Grande Do Sul</state>
        <zip>98700-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0402)</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0401)</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01321-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.C. Camargo Cancer Center ( Site 0405)</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01509-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Center ( Site 0014)</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. H. Bliss Murphy Cancer Centre ( Site 0001)</name>
      <address>
        <city>Saint John S</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1B 3V6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Centre of Southeastern Ontario at Kingston General Hospital ( Site 0004)</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre ( Site 0005)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0003)</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://merckoncologyclinicaltrials.com</url>
    <description>Merck Oncology Clinical Trials Information</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 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 Death-Ligand 1 (PDL1, PD-L1)</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04489888
org study id: 3475-B10
secondary id: MK-3475-B10
nct id: NCT04489888
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with
      carboplatin and paclitaxel as first line treatment in participants with recurrent/metastatic
      head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested
      in this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: Up to ~20 months
description: ORR is defined as the percentage of participants who have 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 of diameters) per Response Evaluation Criteria in Solid Tumors Update and Clarification 1.1 (RECIST 1.1) which has been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
measure: Duration of Response (DOR)
time frame: Up to ~47 months
description: For participants who demonstrate a confirmed Complete Response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. RECIST 1.1 has been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
measure: Progression-free Survival (PFS)
time frame: Up to ~47 months
description: PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independent central review based on RECIST 1.1 will be presented.
measure: Overall Survival (OS)
time frame: Up to ~47 months
description: OS is defined as the time from first dose of study treatment to death due to any cause.
measure: Percentage of Participants who Experience an Adverse Event (AE)
time frame: Up to ~27 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience an AE will be reported.
measure: Percentage of Participants who Discontinue Study Treatment due to an AE
time frame: Up to ~24 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
arm group label: Pembrolizumab + Carboplatin + Paclitaxel
arm group type: Experimental
description: Participants will receive pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab will be administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Carboplatin will be administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). At investigator's choice, paclitaxel will be administered via IV infusion at a dose of 100 mg/m^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to ~4 months) or at a dose of 175 mg/m^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months).
intervention type: Drug
intervention name: Pembrolizumab
description: Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle
arm group label: Pembrolizumab + Carboplatin + Paclitaxel
other name: MK-3475
other name: KEYTRUDA®
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle
arm group label: Pembrolizumab + Carboplatin + Paclitaxel
other name: PARAPLATIN®
intervention type: Drug
intervention name: Paclitaxel
description: At investigator's choice, paclitaxel 100 mg/m^2 IV infusion given on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each 21-day cycle
arm group label: Pembrolizumab + Carboplatin + Paclitaxel
other name: TAXOL®
other name: ONXAL®
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
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country: Argentina
country: Australia
country: Brazil
country: Canada
country: United States
url: http://merckoncologyclinicaltrials.com
description: Merck Oncology Clinical Trials Information
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Paclitaxel
mesh term: Carboplatin
mesh term: Pembrolizumab
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php