<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/NCT03776136</url>
  </required_header>
  <id_info>
    <org_study_id>7902-004</org_study_id>
    <secondary_id>MK-7902-004</secondary_id>
    <secondary_id>E7080-G000-225</secondary_id>
    <secondary_id>LEAP-004</secondary_id>
    <secondary_id>2018-002518-10</secondary_id>
    <nct_id>NCT03776136</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)</brief_title>
  <official_title>A Multicenter, Open-label, Phase 2 Trial to Assess the Efficacy and Safety of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Melanoma Previously Exposed to an Anti-PD-1/L1 Agent (LEAP-004)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety and efficacy of combination therapy of lenvatinib&#xD;
      (E7080/MK-7902) and pembrolizumab following approximately 2 years of pembrolizumab therapy&#xD;
      and approximately 2 years or more lenvatinib therapy in adult participants with unresectable&#xD;
      or advanced melanoma who have been exposed to anti-PD-1/L1 agents approved for unresectable&#xD;
      or metastatic melanoma. No statistical hypothesis will be tested in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">October 11, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 11, 2023</primary_completion_date>
  <phase>Phase 2</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) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) per RECIST 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>PFS is defined as the time from the first day of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the RECIST 1.1 as assessed by BICR. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>OS is defined as the time from the first day of study treatment to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>DOR is defined as the time from first documented evidence of CR or PR, per RECIST 1.1 as assessed by BICR, until disease progression or death due to any cause, whichever occurs first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experience At Least One Adverse Event (AE)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience at least one AE will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinue study treatment due to an AE will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration Time Curve of Lenvatinib From Time 0 to Infinity (AUC 0-inf)</measure>
    <time_frame>At designated time points on Day 1 and Day 15 of Cycle 1 (21-day cycle) and Day 1 of Cycle 2 (21-day cycle)</time_frame>
    <description>Blood samples will be obtained on Day 1 and Day 15 of Cycle 1 (21-day cycle) and Day 1 of Cycle 2 (21-day cycle) for pharmacokinetic (PK) analysis to determine the AUC of lenvatinib.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Advanced Melanoma</condition>
  <arm_group>
    <arm_group_label>lenvatinib plus pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lenvatinib</intervention_name>
    <description>Administered orally once a day during each 21-day cycle.</description>
    <arm_group_label>lenvatinib plus pembrolizumab</arm_group_label>
    <other_name>MK-7902</other_name>
    <other_name>E7080</other_name>
    <other_name>LENVIMA™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>pembrolizumab</intervention_name>
    <description>Administered as an IV infusion on Day 1 Q3W.</description>
    <arm_group_label>lenvatinib plus pembrolizumab</arm_group_label>
    <other_name>MK-3475</other_name>
    <other_name>Keytruda®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has histologically or cytologically confirmed melanoma&#xD;
&#xD;
          -  Has unresectable Stage III or Stage IV melanoma per American Joint Committee on Cancer&#xD;
             (AJCC) staging system version 8 that is not amenable to local therapy&#xD;
&#xD;
          -  Has the presence of ≥1 measurable lesion by computed tomography (CT) or magnetic&#xD;
             resonance imaging (MRI) per RECIST 1.1 as confirmed by BICR.&#xD;
&#xD;
          -  Has progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb)&#xD;
             administered either as monotherapy, or in combination with other checkpoint inhibitors&#xD;
             or other therapies&#xD;
&#xD;
          -  Has submitted pre-trial imaging&#xD;
&#xD;
          -  Has an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1&#xD;
&#xD;
          -  Has provided a baseline tumor biopsy&#xD;
&#xD;
          -  Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less&#xD;
             (except alopecia). If participant received major surgery or radiation therapy of &gt;30&#xD;
             Gray (Gy), they must have recovered from the toxicity and/or complications from the&#xD;
             Intervention&#xD;
&#xD;
          -  Male participants must agree to use approved contraception during the treatment period&#xD;
             and for at least 120 days after the last dose of study intervention and refrain from&#xD;
             donating sperm during this period&#xD;
&#xD;
          -  Female participants are not pregnant and not breastfeeding, and are not a woman of&#xD;
             childbearing potential (WOCBP) or are a WOCBP who agrees to follow contraceptive&#xD;
             guidance during the treatment period and for at least 120 days after the last dose of&#xD;
             study intervention&#xD;
&#xD;
          -  Has adequate organ function&#xD;
&#xD;
        Exclusion Criteria:&#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 before the first dose of study treatment&#xD;
&#xD;
          -  Has a known additional malignancy that is progressing or requires active treatment&#xD;
&#xD;
          -  Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis&#xD;
&#xD;
          -  Has ocular melanoma&#xD;
&#xD;
          -  Has known hypersensitivity to active substances or any of their excipients including&#xD;
             previous clinically significant hypersensitivity reaction to treatment with another&#xD;
             monoclonal antibody&#xD;
&#xD;
          -  Has an active autoimmune disease that has required systemic treatment in past 2 years&#xD;
             (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs)&#xD;
&#xD;
          -  Has an active infection requiring systemic therapy&#xD;
&#xD;
          -  Has known history of Human Immunodeficiency Virus (HIV) or HIV 1/2 antibodies&#xD;
&#xD;
          -  Has known history of or is positive for hepatitis B (hepatitis B surface antigen&#xD;
             [HBsAg] reactive) or hepatitis C (HCV RNA qualitative] is detected)&#xD;
&#xD;
          -  Has a history of (non-infectious) pneumonitis/interstitial lung disease that required&#xD;
             steroids or current pneumonitis/interstitial lung disease&#xD;
&#xD;
          -  Has a history of active tuberculosis (Bacillus tuberculosis)&#xD;
&#xD;
          -  Has presence of a gastrointestinal condition including malabsorption, gastrointestinal&#xD;
             anastomosis, or any other condition that might affect the absorption of lenvatinib&#xD;
&#xD;
          -  Has had major surgery within 4 weeks prior to first dose of study interventions&#xD;
             (adequate wound healing after major surgery must be assessed clinically, independent&#xD;
             of time elapsed for eligibility)&#xD;
&#xD;
          -  Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula&#xD;
&#xD;
          -  Has radiographic evidence of major blood vessel invasion/infiltration&#xD;
&#xD;
          -  Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the&#xD;
             first dose of study drug&#xD;
&#xD;
          -  Has clinically significant cardiovascular disease within 12 months from first dose of&#xD;
             study drug, including New York Heart Association Class III or IV congestive heart&#xD;
             failure, unstable angina, myocardial infarction, cerebral vascular accident, or&#xD;
             cardiac arrhythmia associated with hemodynamic instability&#xD;
&#xD;
          -  Has received prior radiotherapy within 2 weeks of Cycle 1 Day 1 with the exception of&#xD;
             palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks prior&#xD;
             to Cycle 1 Day 1&#xD;
&#xD;
          -  Has received a live vaccine within 30 days before the first dose of study treatment&#xD;
&#xD;
          -  Is currently participating in or has participated in a study of an investigational&#xD;
             agent or has used an investigational device within 4 weeks prior to the first dose of&#xD;
             study treatment&#xD;
&#xD;
          -  Has a history or has current evidence of any condition, therapy, or laboratory&#xD;
             abnormality that might confound the results of the study, interfere with the&#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 had an allogeneic tissue/solid organ transplant&#xD;
&#xD;
          -  Has a known psychiatric or substance abuse disorder that would interfere with&#xD;
             cooperation with the requirements of the study&#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>Ironwood Cancer &amp; Research Centers ( Site 0312)</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Wayne Cancer Institute ( Site 0301)</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Medical Group-Park Ridge ( Site 0313)</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Nebraska Cancer Center ( Site 0316)</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0317)</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Schar Cancer Institute ( Site 0314)</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031-4867</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melanoma Institute Australia ( Site 0152)</name>
      <address>
        <city>Wollstonecraft</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital ( Site 0154)</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Box Hill Hospital ( Site 0157)</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fiona Stanley Hospital ( Site 0156)</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lismore Base Hospital ( Site 0153)</name>
      <address>
        <city>Lismore</city>
        <zip>2480</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Research Institute ( Site 0654)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre ( Site 0655)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0652)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre ( Site 0651)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial Barcelona ( Site 0001)</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon ( Site 0003)</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Macarena ( Site 0004)</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia ( Site 0002)</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska Universitetssjukhuset ( Site 0052)</name>
      <address>
        <city>Goteborg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skanes Universitetssjukhus ( Site 0053)</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset ( Site 0051)</name>
      <address>
        <city>Solna</city>
        <zip>171 64</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norrlands Universitetssjukhus ( Site 0056)</name>
      <address>
        <city>Umea</city>
        <zip>901 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.merckclinicaltrials.com/</url>
    <description>Merck Clinical Trials Information</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>September 4, 2023</last_update_submitted>
  <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>programmed cell death 1 (PD-1, PD1)</keyword>
  <keyword>programmed cell death ligand 1 (PD-L1, PDL1)</keyword>
  <keyword>programmed cell death ligand 2 (PD-L2, PDL2)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Lenvatinib</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/NCT03776136
org study id: 7902-004
secondary id: MK-7902-004
secondary id: E7080-G000-225
secondary id: LEAP-004
secondary id: 2018-002518-10
nct id: NCT03776136
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the safety and efficacy of combination therapy of lenvatinib
      (E7080/MK-7902) and pembrolizumab following approximately 2 years of pembrolizumab therapy
      and approximately 2 years or more lenvatinib therapy in adult participants with unresectable
      or advanced melanoma who have been exposed to anti-PD-1/L1 agents approved for unresectable
      or metastatic melanoma. 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) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
time frame: Up to 3 years
description: ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) per RECIST 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
measure: Progression-free Survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
time frame: Up to 3 years
description: PFS is defined as the time from the first day of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the RECIST 1.1 as assessed by BICR. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
measure: Overall Survival (OS)
time frame: Up to 3 years
description: OS is defined as the time from the first day of study treatment to death due to any cause.
measure: Duration of Response (DOR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
time frame: Up to 3 years
description: DOR is defined as the time from first documented evidence of CR or PR, per RECIST 1.1 as assessed by BICR, until disease progression or death due to any cause, whichever occurs first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
measure: Percentage of Participants Who Experience At Least One Adverse Event (AE)
time frame: Up to 3 years
description: An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience at least one AE will be reported.
measure: Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
time frame: Up to 3 years
description: An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinue study treatment due to an AE will be reported.
measure: Area Under the Concentration Time Curve of Lenvatinib From Time 0 to Infinity (AUC 0-inf)
time frame: At designated time points on Day 1 and Day 15 of Cycle 1 (21-day cycle) and Day 1 of Cycle 2 (21-day cycle)
description: Blood samples will be obtained on Day 1 and Day 15 of Cycle 1 (21-day cycle) and Day 1 of Cycle 2 (21-day cycle) for pharmacokinetic (PK) analysis to determine the AUC of lenvatinib.
arm group label: lenvatinib plus pembrolizumab
arm group type: Experimental
description: Participants receive lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.
intervention type: Drug
intervention name: lenvatinib
description: Administered orally once a day during each 21-day cycle.
arm group label: lenvatinib plus pembrolizumab
other name: MK-7902
other name: E7080
other name: LENVIMA™
intervention type: Biological
intervention name: pembrolizumab
description: Administered as an IV infusion on Day 1 Q3W.
arm group label: lenvatinib plus pembrolizumab
other name: MK-3475
other name: Keytruda®
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: Australia
country: Canada
country: Spain
country: Sweden
country: United States
url: https://www.merckclinicaltrials.com/
description: Merck Clinical Trials Information
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Pembrolizumab
mesh term: Lenvatinib
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php