xml: <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/NCT06036836</url>
    </required_header>
    <id_info>
      <org_study_id>4280A-010</org_study_id>
      <secondary_id>MK-4280A-010</secondary_id>
      <secondary_id>2023-505022-34</secondary_id>
      <nct_id>NCT06036836</nct_id>
    </id_info>
    <brief_title>Study of Favelizimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)</brief_title>
    <official_title>A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) With Pembrolizumab (MK-3475) in Selected Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Merck Sharp &amp; Dohme LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Merck Sharp &amp; Dohme LLC</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate pathological complete response (pCR) rate of&#xD;
        coformulated favezelimab/pembrolizumab (MK-4280A) or pembrolizumab as assessed by blinded&#xD;
        central pathology review (BICR) in participants with cutaneous squamous cell carcinoma (cSCC)&#xD;
        [Cohort A] and to evaluate lenvatinib in combination with coformulated&#xD;
        favezelimab/pembrolizumab or pembrolizumab with respect to objective response rate (ORR) per&#xD;
        Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator in&#xD;
        participants proficient in mismatch repair (pMMR) endometrial cancer (EC) [Cohort B].&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 26, 2023</start_date>
    <completion_date type="Anticipated">March 9, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 9, 2027</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pathological Complete Response (pCR) - Cohort A</measure>
      <time_frame>Up to approximately 22 months</time_frame>
      <description>pCR is defined as complete absence of viable tumor in the surgical resection sample as assessed by central review of the pathology results. Number of Cohort A participants with pCR will be reported.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Investigator - Cohort B</measure>
      <time_frame>Up to approximately 21 months</time_frame>
      <description>The ORR is defined as the percentage of participants who have an OR per investigator assessment. The OR is defined as a 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 experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS) - All Cohorts</measure>
      <time_frame>Up to approximately 41 months</time_frame>
      <description>OS is defined as the time from randomization to death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Benefit Rate - Cohort A</measure>
      <time_frame>Up to approximately 22 months</time_frame>
      <description>Clinical benefit rate is defined as the percentage of participants who have clinical benefit. Clinical benefit is defined as pCR in participants who undergo surgery or clinical complete response (cCR) [defined as residual tumor not visible on clinical exam or on imaging and a negative biopsy, if biopsy is available, in participants who decline surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Event-Free Survival (EFS) - Cohort A</measure>
      <time_frame>Up to approximately 41 months</time_frame>
      <description>EFS is defined as the time from randomization to first progression prior to surgical resection as assessed by investigator, inability to resect tumor, recurrence (postsurgical resection), or death from any cause, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Major Pathological Response (mPR) - Cohort A</measure>
      <time_frame>Up to approximately 22 months</time_frame>
      <description>mPR is defined as ≤10% of viable tumor cells in the surgical resection sample as assessed by central review of the pathology results. The number of Cohort A participants with mPR will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ORR per RECIST 1.1 as assessed by Investigator - Cohort A</measure>
      <time_frame>Up to approximately 22 months</time_frame>
      <description>The ORR is defined as the percentage of participants who have an OR per investigator assessment. The OR is defined as a 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 experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with an adverse event (AE) - Cohorts A and B</measure>
      <time_frame>Up to approximately 41 months</time_frame>
      <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who experience an AE will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants discontinuing from study therapy due to AE - Cohorts A and B</measure>
      <time_frame>Up to approximately 41 months</time_frame>
      <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants experiencing perioperative complications - Cohort A</measure>
      <time_frame>Up to approximately 18 weeks</time_frame>
      <description>The number of participants who experience perioperative complications will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with an AE that precludes surgery/initiation of adjuvant therapy - Cohort A</measure>
      <time_frame>Up to approximately 2 months</time_frame>
      <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of Cohort A participants with an AE that precludes surgery or initiation of adjuvant therapy will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS) - Cohort B</measure>
      <time_frame>Up to approximately 41 months</time_frame>
      <description>PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by the investigator. Per RECIST 1.1, or by histopathologic confirmation of disease progression (PD), 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. Unequivocal progression of non-target lesions is also considered PD.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR) - Cohort B</measure>
      <time_frame>Up to approximately 41 months</time_frame>
      <description>DOR is defined as the time from first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Solid Tumor</condition>
    <condition>Cutaneous Squamous Cell Carcinoma</condition>
    <condition>Endometrial Cancer</condition>
    <arm_group>
      <arm_group_label>Favezelimab/Pembrolizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via an intravenous (IV) infusion every 3 weeks (Q3W) for up to 3 cycles in the neoadjuvant period and up to 14 cycles of adjuvant therapy. Each cycle is 21 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pembrolizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 200 mg pembrolizumab via an IV infusion Q3W for up to 3 cycles in the neoadjuvant period and up to 14 cycles of adjuvant therapy. Each cycle is 21 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Favezelimab/Pembrolizumab + Lenvatinib (Cohort B)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib every day (QD) 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pembrolizumab + Lenvatinib (Cohort B)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 200 mg pembrolizumab via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib QD 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>favezelimab/pembrolizumab</intervention_name>
      <description>IV infusion</description>
      <arm_group_label>Favezelimab/Pembrolizumab</arm_group_label>
      <arm_group_label>Favezelimab/Pembrolizumab + Lenvatinib (Cohort B)</arm_group_label>
      <other_name>MK-4280A</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>pembrolizumab</intervention_name>
      <description>IV infusion</description>
      <arm_group_label>Pembrolizumab</arm_group_label>
      <arm_group_label>Pembrolizumab + Lenvatinib (Cohort B)</arm_group_label>
      <other_name>MK-3475</other_name>
      <other_name>Keytruda®</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>lenvatinib</intervention_name>
      <description>Oral administration of capsule</description>
      <arm_group_label>Favezelimab/Pembrolizumab + Lenvatinib (Cohort B)</arm_group_label>
      <arm_group_label>Pembrolizumab + Lenvatinib (Cohort B)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
          Cohort A only&#xD;
  &#xD;
            -  Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma&#xD;
               (cSCC) as the primary site of malignancy (metastatic skin involvement from another&#xD;
               primary cancer or from an unknown primary cancer is not permitted)&#xD;
  &#xD;
            -  Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in&#xD;
               the head and neck will be staged according to American Joint Committee on Cancer&#xD;
               (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be&#xD;
               staged according to Union for International Cancer Control (UICC) Ed. 9&#xD;
  &#xD;
            -  Is systemic treatment naïve&#xD;
  &#xD;
            -  Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample&#xD;
               of a tumor lesion not previously irradiated has been provided&#xD;
  &#xD;
            -  Is an individual of any sex/gender, at least 18 years of age at the time of providing&#xD;
               the informed consent&#xD;
  &#xD;
          Cohort B only&#xD;
  &#xD;
            -  Histologically confirmed diagnosis of endometrial cancer (EC) that is not deficient in&#xD;
               mismatch repair (dMMR) proficient in mismatch repair (pMMR) as documented by a local&#xD;
               test report&#xD;
  &#xD;
            -  Documented evidence of stage IVB (per International Federation of Gynecology and&#xD;
               Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for&#xD;
               curative surgery or radiation&#xD;
  &#xD;
            -  Has radiographic evidence of disease progression after 1 prior systemic,&#xD;
               platinum-based chemotherapy regimen for EC in any setting&#xD;
  &#xD;
            -  Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by&#xD;
               investigator (before first dose of study intervention)&#xD;
  &#xD;
            -  Is assigned female sex at birth, at least 18 years of age at the time of providing the&#xD;
               informed consent&#xD;
  &#xD;
            -  Has adequately controlled blood pressure without antihypertensive medication&#xD;
  &#xD;
          All Cohorts&#xD;
  &#xD;
            -  Agrees to follow contraception guidelines if a participant of childbearing potential&#xD;
  &#xD;
            -  Has a life expectancy &gt;3 years per investigator assessment&#xD;
  &#xD;
            -  Has adequate organ function&#xD;
  &#xD;
            -  Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
  &#xD;
            -  If positive for hepatitis B, has received antiviral therapy for ≥4 weeks and&#xD;
               undetectable viral load prior to randomization&#xD;
  &#xD;
            -  If positive for hepatitis C, has undetectable viral load at screening&#xD;
  &#xD;
            -  If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a&#xD;
               stable highly active antiretroviral therapy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          All Cohorts&#xD;
  &#xD;
            -  Has known hypersensitivity to active substances or their excipients including previous&#xD;
               clinically significant hypersensitivity reaction to treatment with other monoclonal&#xD;
               antibody (mAb)&#xD;
  &#xD;
            -  History of allogeneic tissue/solid organ transplant&#xD;
  &#xD;
          Cohort A only&#xD;
  &#xD;
            -  Received prior radiotherapy to the index lesion (in-field lesion)&#xD;
  &#xD;
            -  Participants for whom the primary site of cSCC was anogenital area (penis, scrotum,&#xD;
               vulva, perianal region) are not eligible&#xD;
  &#xD;
          Cohort B&#xD;
  &#xD;
            -  Has had major surgery within 3 weeks prior to first dose of study interventions&#xD;
  &#xD;
            -  Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula&#xD;
  &#xD;
            -  Has urine protein ≥1 g/24 hours&#xD;
  &#xD;
            -  Has a left ventricle ejection fraction (LVEF) below the institutional (or local&#xD;
               laboratory) normal range, as determined by multi-gated acquisition (MUGA) or&#xD;
               echocardiogram (ECHO)&#xD;
  &#xD;
            -  Has radiographic evidence of encasement or invasion of a major blood vessel, or of&#xD;
               intratumoral cavitation&#xD;
  &#xD;
            -  Has clinically significant cardiovascular disease within 12 months from first dose of&#xD;
               study intervention&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Cohort A Only - Participant is an individual of any sex/gender&#xD;
  Cohort B Only - Participant is assigned female sex at birth</gender_description>
      <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>
    <link>
      <url>http://www.merckclinicaltrials.com</url>
      <description>Merck Clinical Trials Information</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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-2 (PD2, PD-2)</keyword>
    <keyword>Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1)</keyword>
    <keyword>Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)</keyword>
    <keyword>Lymphocyte-Activation Gene 3 (LAG-3)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometrial Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pembrolizumab</mesh_term>
      <mesh_term>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>
  
  
text: 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/NCT06036836
  org study id: 4280A-010
  secondary id: MK-4280A-010
  secondary id: 2023-505022-34
  nct id: NCT06036836
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate pathological complete response (pCR) rate of
        coformulated favezelimab/pembrolizumab (MK-4280A) or pembrolizumab as assessed by blinded
        central pathology review (BICR) in participants with cutaneous squamous cell carcinoma (cSCC)
        [Cohort A] and to evaluate lenvatinib in combination with coformulated
        favezelimab/pembrolizumab or pembrolizumab with respect to objective response rate (ORR) per
        Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator in
        participants proficient in mismatch repair (pMMR) endometrial cancer (EC) [Cohort B].
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Pathological Complete Response (pCR) - Cohort A
  time frame: Up to approximately 22 months
  description: pCR is defined as complete absence of viable tumor in the surgical resection sample as assessed by central review of the pathology results. Number of Cohort A participants with pCR will be reported.
  measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Investigator - Cohort B
  time frame: Up to approximately 21 months
  description: The ORR is defined as the percentage of participants who have an OR per investigator assessment. The OR is defined as a 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 experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
  measure: Overall Survival (OS) - All Cohorts
  time frame: Up to approximately 41 months
  description: OS is defined as the time from randomization to death from any cause.
  measure: Clinical Benefit Rate - Cohort A
  time frame: Up to approximately 22 months
  description: Clinical benefit rate is defined as the percentage of participants who have clinical benefit. Clinical benefit is defined as pCR in participants who undergo surgery or clinical complete response (cCR) [defined as residual tumor not visible on clinical exam or on imaging and a negative biopsy, if biopsy is available, in participants who decline surgery.
  measure: Event-Free Survival (EFS) - Cohort A
  time frame: Up to approximately 41 months
  description: EFS is defined as the time from randomization to first progression prior to surgical resection as assessed by investigator, inability to resect tumor, recurrence (postsurgical resection), or death from any cause, whichever occurs first.
  measure: Major Pathological Response (mPR) - Cohort A
  time frame: Up to approximately 22 months
  description: mPR is defined as ≤10% of viable tumor cells in the surgical resection sample as assessed by central review of the pathology results. The number of Cohort A participants with mPR will be reported.
  measure: ORR per RECIST 1.1 as assessed by Investigator - Cohort A
  time frame: Up to approximately 22 months
  description: The ORR is defined as the percentage of participants who have an OR per investigator assessment. The OR is defined as a 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 experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
  measure: Number of participants with an adverse event (AE) - Cohorts A and B
  time frame: Up to approximately 41 months
  description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who experience an AE will be reported.
  measure: Number of participants discontinuing from study therapy due to AE - Cohorts A and B
  time frame: Up to approximately 41 months
  description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be reported.
  measure: Number of participants experiencing perioperative complications - Cohort A
  time frame: Up to approximately 18 weeks
  description: The number of participants who experience perioperative complications will be assessed.
  measure: Number of participants with an AE that precludes surgery/initiation of adjuvant therapy - Cohort A
  time frame: Up to approximately 2 months
  description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of Cohort A participants with an AE that precludes surgery or initiation of adjuvant therapy will be reported.
  measure: Progression Free Survival (PFS) - Cohort B
  time frame: Up to approximately 41 months
  description: PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by the investigator. Per RECIST 1.1, or by histopathologic confirmation of disease progression (PD), 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. Unequivocal progression of non-target lesions is also considered PD.
  measure: Duration of Response (DOR) - Cohort B
  time frame: Up to approximately 41 months
  description: DOR is defined as the time from first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented.
  arm group label: Favezelimab/Pembrolizumab
  arm group type: Experimental
  description: Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via an intravenous (IV) infusion every 3 weeks (Q3W) for up to 3 cycles in the neoadjuvant period and up to 14 cycles of adjuvant therapy. Each cycle is 21 days.
  arm group label: Pembrolizumab
  arm group type: Experimental
  description: Participants will receive 200 mg pembrolizumab via an IV infusion Q3W for up to 3 cycles in the neoadjuvant period and up to 14 cycles of adjuvant therapy. Each cycle is 21 days.
  arm group label: Favezelimab/Pembrolizumab + Lenvatinib (Cohort B)
  arm group type: Experimental
  description: Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib every day (QD) 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met.
  arm group label: Pembrolizumab + Lenvatinib (Cohort B)
  arm group type: Experimental
  description: Participants will receive 200 mg pembrolizumab via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib QD 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met.
  intervention type: Biological
  intervention name: favezelimab/pembrolizumab
  description: IV infusion
  arm group label: Favezelimab/Pembrolizumab
  arm group label: Favezelimab/Pembrolizumab + Lenvatinib (Cohort B)
  other name: MK-4280A
  intervention type: Biological
  intervention name: pembrolizumab
  description: IV infusion
  arm group label: Pembrolizumab
  arm group label: Pembrolizumab + Lenvatinib (Cohort B)
  other name: MK-3475
  other name: Keytruda®
  intervention type: Drug
  intervention name: lenvatinib
  description: Oral administration of capsule
  arm group label: Favezelimab/Pembrolizumab + Lenvatinib (Cohort B)
  arm group label: Pembrolizumab + Lenvatinib (Cohort B)
  criteria: 
  gender: All
  gender based: Yes
  gender description: Cohort A Only - Participant is an individual of any sex/gender
  Cohort B Only - Participant is assigned female sex at birth
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Medical Director
  role: Study Director
  affiliation: Merck Sharp & Dohme LLC
  url: http://www.merckclinicaltrials.com
  description: Merck Clinical Trials Information
  responsible party type: Sponsor
  mesh term: Endometrial Neoplasms
  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