<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/NCT03783078</url>
  </required_header>
  <id_info>
    <org_study_id>3475-913</org_study_id>
    <secondary_id>MK-3475-913</secondary_id>
    <secondary_id>KEYNOTE-913</secondary_id>
    <secondary_id>2018-002601-57</secondary_id>
    <nct_id>NCT03783078</nct_id>
  </id_info>
  <brief_title>Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)</brief_title>
  <official_title>A Phase 3 Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) as First Line Therapy in Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-913)</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>
      This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in&#xD;
      adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma&#xD;
      (MCC). The primary objective of the trial is to assess the objective response rate, as&#xD;
      assessed by blinded independent central review per Response Evaluation Criteria in Solid&#xD;
      Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a&#xD;
      maximum of 5 target lesions per organ, following administration of pembrolizumab.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Anticipated">June 16, 2032</completion_date>
  <primary_completion_date type="Actual">February 15, 2022</primary_completion_date>
  <phase>Phase 3</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 ~34 months</time_frame>
    <description>ORR was defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by blinded independent central review (BICR) were presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to ~13 years</time_frame>
    <description>For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis will be censored at the date of their last tumor assessment. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions is also considered PD. DOR assessments will be based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experience a confirmed CR or PR will be presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>Up to ~13 years</time_frame>
    <description>Progression-Free Survival is defined as the time from the first dose of study treatment to the first documented evidence of disease progression per RECIST 1.1 by BICR 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. PFS as assessed by BICR per RECIST 1.1 will be presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to ~13 years</time_frame>
    <description>OS is defined as the time from the first dose of study treatment until death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With One or More Adverse Events (AEs)</measure>
    <time_frame>Up to ~13 years</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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued From Study Treatment Due to an AE</measure>
    <time_frame>Up to ~13 years</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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue from study treatment due to an AE will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Merkel Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pembrolizumab (MK-3475) 200 mg (adult participants) or 2 mg/kg (up to 200 mg; pediatric participants) on Day 1 of each 3-week cycle (Q3W) intravenous (IV), for up to 35 administrations (approximately 2 years)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab (MK-3475)</intervention_name>
    <description>200 mg (adult participants) or 2 mg/kg (up to 200 mg; pediatric participants) on Day 1 of each 3-week cycle (Q3W) IV up to 35 administrations (approximately 2 years).</description>
    <arm_group_label>Pembrolizumab</arm_group_label>
    <other_name>MK-3475</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be male or female and at least 12 years of age, at the time of signing the informed&#xD;
             consent/assent.&#xD;
&#xD;
          -  Have histologically confirmed diagnosis of locoregional MCC that has recurred&#xD;
             following standard locoregional therapy with surgery and/or radiation therapy and is&#xD;
             not amenable to local therapy or metastatic MCC (Stage IV) as per American Joint&#xD;
             Committee on Cancer (AJCC) 8th edition guidelines.&#xD;
&#xD;
          -  Have been untreated for advanced or metastatic disease except as follows:&#xD;
&#xD;
               1. Prior intratumoral therapy will be permitted.&#xD;
&#xD;
               2. Prior adjuvant or neoadjuvant therapy containing systemic chemotherapy will be&#xD;
                  permitted if treatment concluded at least 3 months prior to Cycle 1 Day 1 (C1D1).&#xD;
&#xD;
               3. Prior adjuvant or neoadjuvant therapy containing anti-PD-1/L1 or anti-CTLA-4&#xD;
                  (cytotoxic T-lymphocyte-associated protein 4) therapy will not be permitted.&#xD;
&#xD;
          -  Have at least 1 measurable lesion by computed tomography (CT) or magnetic resonance&#xD;
             imaging (MRI) per RECIST 1.1 criteria as determined by the local site&#xD;
             investigator/radiology assessment.&#xD;
&#xD;
          -  Toxic effect(s) of the most recent prior therapy have resolved to Grade 1 or less&#xD;
             (except alopecia).&#xD;
&#xD;
          -  Contraceptive use by men should be consistent with local regulations regarding the&#xD;
             methods of contraception for those participating in clinical studies.&#xD;
&#xD;
          -  Contraceptive use by women should be consistent with local regulations regarding the&#xD;
             methods of contraception for those participating in clinical studies.&#xD;
&#xD;
          -  A female participant is eligible to participate if she is not pregnant or&#xD;
             breastfeeding, and at least one of the following conditions applies:&#xD;
&#xD;
          -  Is not a woman of childbearing potential (WOCBP)&#xD;
&#xD;
          -  OR&#xD;
&#xD;
          -  Is a WOCBP and using a contraceptive method that is highly effective (with a failure&#xD;
             rate of &lt;1% per year), with low user dependency, or be abstinent from heterosexual&#xD;
             intercourse as their preferred and usual lifestyle (abstinent on a long term and&#xD;
             persistent basis).&#xD;
&#xD;
          -  A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as&#xD;
             required by local regulations) within 72 hours before the first dose of study&#xD;
             intervention.&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or&#xD;
             Lansky Play-Performance Scale (LPS) ≥50 for pediatric participants up to and including&#xD;
             16 years of age.&#xD;
&#xD;
          -  Have adequate organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a known additional malignancy that is progressing or has required active treatment&#xD;
             within the past 2 years with certain exceptions.&#xD;
&#xD;
          -  Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis with certain exceptions.&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy&#xD;
             (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of&#xD;
             immunosuppressive therapy within 7 days prior to C1D1.&#xD;
&#xD;
          -  Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.&#xD;
&#xD;
          -  Has an active autoimmune disease that has required systemic treatment in past 2 years&#xD;
             (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive&#xD;
             drugs).&#xD;
&#xD;
          -  Has a history of (non-infectious) pneumonitis/interstitial lung disease that required&#xD;
             steroids or has current pneumonitis/interstitial lung disease.&#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 (defined as Hepatitis B surface antigen [HBsAg]&#xD;
             reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is&#xD;
             detected) infection.&#xD;
&#xD;
          -  Has a known history of active tuberculosis (TB; Bacillus tuberculosis).&#xD;
&#xD;
          -  Has clinically significant cardiac disease within 6 months of C1D1, including New York&#xD;
             Heart Association Class III or IV congestive heart failure, unstable angina,&#xD;
             myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated&#xD;
             with hemodynamic instability.&#xD;
&#xD;
          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
             that might confound the results of the study, interfere with the participant's&#xD;
             participation for the full duration of the study, or is not in the best interest of&#xD;
             the participant to participate, in the opinion of the treating investigator.&#xD;
&#xD;
          -  Has a known psychiatric or substance abuse disorder that would interfere with the&#xD;
             participant's ability to cooperate with the requirements of the study.&#xD;
&#xD;
          -  Has not received standard locoregional therapy with surgery and/or radiation therapy&#xD;
             for the treatment of local or locoregional disease. Note: This exclusion criterion&#xD;
             does not apply to participants who are diagnosed with unresectable or metastatic MCC.&#xD;
&#xD;
          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with&#xD;
             an agent directed to another stimulatory or co-inhibitory T-cell receptor.&#xD;
&#xD;
          -  Has received prior systemic anticancer therapy including investigational agents within&#xD;
             12 weeks prior to C1D1.&#xD;
&#xD;
          -  Has received radiotherapy within 2 weeks prior to start of study intervention.&#xD;
&#xD;
          -  Has received a live vaccine within 30 days prior to C1D1.&#xD;
&#xD;
          -  Is currently participating in or has participated in a study of an investigational&#xD;
             agent or has used an investigational device within 4 weeks prior to C1D1.&#xD;
&#xD;
          -  Has had an allogenic tissue/solid organ transplant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 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>Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0006)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai ( Site 0004)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melanoma Institute Australia ( Site 0400)</name>
      <address>
        <city>North Sydney</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calvary Mater Newcastle ( Site 0402)</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moncton Hospital - Horizon Health Network ( Site 0055)</name>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <zip>E1C 6Z8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre ( Site 0051)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Cote de Nacre - Caen ( Site 0204)</name>
      <address>
        <city>Caen</city>
        <state>Calvados</state>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux- Hopital Saint Andre ( Site 0203)</name>
      <address>
        <city>Bordeaux</city>
        <state>Gironde</state>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Ambroise Pare Boulogne ( Site 0201)</name>
      <address>
        <city>Boulogne-Billancourt</city>
        <state>Hauts-de-Seine</state>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H.R.U. de Tours. Hopital Trousseau ( Site 0202)</name>
      <address>
        <city>Chambray Les Tours</city>
        <state>Indre-et-Loire</state>
        <zip>37170</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille - Hopital Claude Huriez ( Site 0200)</name>
      <address>
        <city>Lille</city>
        <state>Nord</state>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Senese ( Site 0224)</name>
      <address>
        <city>Siena</city>
        <state>Toscana</state>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IEO Istituto Europeo di Oncologia ( Site 0223)</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori Fondazione Pascale ( Site 0222)</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto ( Site 0221)</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital ( Site 0427)</name>
      <address>
        <city>Auckland</city>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia ( Site 0262)</name>
      <address>
        <city>Valencia</city>
        <state>Valenciana, Comunitat</state>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d Hebron ( Site 0264)</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona ( Site 0261)</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz ( Site 0263)</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset Solna ( Site 0281)</name>
      <address>
        <city>Solna</city>
        <state>Stockholms Lan</state>
        <zip>171 64</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska Universitetssjukhuset ( Site 0282)</name>
      <address>
        <city>Goeteborg</city>
        <state>Vastra Gotalands Lan</state>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Italy</country>
    <country>New Zealand</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://merckoncologyclinicaltrials.com</url>
    <description>Merck Oncology Clinical Trials Information</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>January 25, 2023</results_first_submitted>
  <results_first_submitted_qc>January 25, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2023</results_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 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>
  <keyword>Merkel cell carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Merkel Cell</mesh_term>
    <mesh_term>Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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 and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 1, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03783078/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants of at least 12 years of age with advanced Merkel cell carcinoma (MCC) were recruited to evaluate the safety and efficacy of Pembrolizumab (MK-3475) as first-line therapy.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Pembrolizumab 200 mg</title>
          <description>Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 of each 3-week cycle (Q3W) intravenously (IV), for up to 35 administrations (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="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participants Ongoing</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </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>Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 of each 3-week cycle (Q3W) intravenously (IV), for up to 35 administrations (approximately 2 years).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
          </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="72.5" spread="11.7"/>
                  </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="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>ORR was defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by blinded independent central review (BICR) were presented.</description>
        <time_frame>Up to ~34 months</time_frame>
        <population>The analysis population consisted of all allocated participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 200 mg</title>
            <description>Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 of each 3-week cycle (Q3W) intravenously (IV), for up to 35 administrations (approximately 2 years).</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>ORR was defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by blinded independent central review (BICR) were presented.</description>
          <population>The analysis population consisted of all allocated participants who received at least 1 dose of study treatment.</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="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.1" lower_limit="35.4" upper_limit="62.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis will be censored at the date of their last tumor assessment. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions is also considered PD. DOR assessments will be based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experience a confirmed CR or PR will be presented.</description>
        <time_frame>Up to ~13 years</time_frame>
        <posting_date>06/2032</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS)</title>
        <description>Progression-Free Survival is defined as the time from the first dose of study treatment to the first documented evidence of disease progression per RECIST 1.1 by BICR 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. PFS as assessed by BICR per RECIST 1.1 will be presented.</description>
        <time_frame>Up to ~13 years</time_frame>
        <posting_date>06/2032</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS is defined as the time from the first dose of study treatment until death from any cause.</description>
        <time_frame>Up to ~13 years</time_frame>
        <posting_date>06/2032</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With One or More Adverse Events (AEs)</title>
        <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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE will be assessed.</description>
        <time_frame>Up to ~13 years</time_frame>
        <posting_date>06/2032</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued From Study Treatment Due to an AE</title>
        <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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue from study treatment due to an AE will be assessed.</description>
        <time_frame>Up to ~13 years</time_frame>
        <posting_date>06/2032</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to ~34 months</time_frame>
      <desc>All-cause mortality includes all allocated participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms &quot;Neoplasm progression&quot;, &quot;Malignant neoplasm progression&quot; and &quot;Disease progression&quot; not related to study treatment were excluded as AEs.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pembrolizumab 200 mg</title>
          <description>Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 of each 3-week cycle (Q3W) intravenously (IV), for up to 35 administrations (approximately 2 years).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="7" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="9" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Chronic inflammatory demyelinating polyradiculoneuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Guillain-Barre syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </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="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="55"/>
              </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="10" subjects_affected="8" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="55"/>
              </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="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="11" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="18" subjects_affected="14" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="55"/>
              </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="6" subjects_affected="5" subjects_at_risk="55"/>
              </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="10" subjects_affected="9" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Actinic keratosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="18" subjects_affected="12" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="55"/>
              </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>If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.</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/NCT03783078
org study id: 3475-913
secondary id: MK-3475-913
secondary id: KEYNOTE-913
secondary id: 2018-002601-57
nct id: NCT03783078
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in
      adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma
      (MCC). The primary objective of the trial is to assess the objective response rate, as
      assessed by blinded independent central review per Response Evaluation Criteria in Solid
      Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a
      maximum of 5 target lesions per organ, following administration of pembrolizumab.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: Up to ~34 months
description: ORR was defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by blinded independent central review (BICR) were presented.
measure: Duration of Response (DOR)
time frame: Up to ~13 years
description: For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis will be censored at the date of their last tumor assessment. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions is also considered PD. DOR assessments will be based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experience a confirmed CR or PR will be presented.
measure: Progression-free Survival (PFS)
time frame: Up to ~13 years
description: Progression-Free Survival is defined as the time from the first dose of study treatment to the first documented evidence of disease progression per RECIST 1.1 by BICR 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. PFS as assessed by BICR per RECIST 1.1 will be presented.
measure: Overall Survival (OS)
time frame: Up to ~13 years
description: OS is defined as the time from the first dose of study treatment until death from any cause.
measure: Number of Participants With One or More Adverse Events (AEs)
time frame: Up to ~13 years
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE will be assessed.
measure: Number of Participants Who Discontinued From Study Treatment Due to an AE
time frame: Up to ~13 years
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue from study treatment due to an AE will be assessed.
arm group label: Pembrolizumab
arm group type: Experimental
description: Pembrolizumab (MK-3475) 200 mg (adult participants) or 2 mg/kg (up to 200 mg; pediatric participants) on Day 1 of each 3-week cycle (Q3W) intravenous (IV), for up to 35 administrations (approximately 2 years)
intervention type: Drug
intervention name: Pembrolizumab (MK-3475)
description: 200 mg (adult participants) or 2 mg/kg (up to 200 mg; pediatric participants) on Day 1 of each 3-week cycle (Q3W) IV up to 35 administrations (approximately 2 years).
arm group label: Pembrolizumab
other name: MK-3475
criteria: 
gender: All
minimum age: 12 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: Australia
country: Canada
country: France
country: Italy
country: New Zealand
country: Spain
country: Sweden
country: United States
url: http://merckoncologyclinicaltrials.com
description: Merck Oncology Clinical Trials Information
responsible party type: Sponsor
mesh term: Carcinoma, Merkel Cell
mesh term: Carcinoma
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: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 