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/NCT06041802</url>
    </required_header>
    <id_info>
      <org_study_id>3475A-E39</org_study_id>
      <secondary_id>MK-3475A-E39</secondary_id>
      <secondary_id>jRCT2041230074</secondary_id>
      <nct_id>NCT06041802</nct_id>
    </id_info>
    <brief_title>A Study of MK-3475A (Pembrolizumab Formulated With MK-5180) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)</brief_title>
    <official_title>A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of MK-3475A in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC.</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>No</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 the efficacy, safety, and tolerability of&#xD;
        subcutaneous (SC) MK-3475A in Japanese participants with recurrent or metastatic cutaneous&#xD;
        squamous cell carcinoma or locally advanced unresectable cSCC. The primary hypothesis is that&#xD;
        MK-3475A will result in greater than 10% objective response rate (ORR) per Response&#xD;
        Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded&#xD;
        Independent Central Review (BICR).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 12, 2023</start_date>
    <completion_date type="Anticipated">March 2, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 2, 2027</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)</measure>
      <time_frame>Up to approximately 40 months</time_frame>
      <description>ORR is 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 experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>Up to approximately 40 months</time_frame>
      <description>For participants who demonstrate CR (disappearance of all target lesions) or 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 CR or PR 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 BICR will be presented.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>Up to approximately 40 months</time_frame>
      <description>DCR is defined, per RECIST 1.1, as the percentage of participants who demonstrate a confirmed CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [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.]).The DCR as assessed by BICR will be presented.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>Up to approximately 40 months</time_frame>
      <description>OS is defined as the time from first dose of study treatment to death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants who Experience an Adverse Event (AE)</measure>
      <time_frame>Up to approximately 30 months</time_frame>
      <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience at least one AE will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants who Discontinue Due to an AE</measure>
      <time_frame>Up to approximately 27 months</time_frame>
      <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">19</enrollment>
    <condition>Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>MK-3475A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive MK-3475A subcutaneously for up to 18 administrations.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>MK-3475A</intervention_name>
      <description>MK-3475A is a fixed-dose formulation of pembrolizumab and MK-5180 for SC administration.</description>
      <arm_group_label>MK-3475A</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          The key inclusion and exclusion criteria include but are not limited to the following:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Has histologically confirmed cSCC by the investigator as the primary site of&#xD;
               malignancy&#xD;
  &#xD;
            -  R/M cSCC cohort only: Has metastatic disease, defined as disseminated disease distant&#xD;
               to the initial/primary site of diagnosis, and/or has locally recurrent disease that&#xD;
               has been previously treated (with either surgery or radiotherapy) and is not curable&#xD;
               by either surgery or radiotherapy&#xD;
  &#xD;
            -  LA unresectable cSCC cohort only: Is ineligible for surgical resection&#xD;
  &#xD;
            -  LA unresectable cSCC cohort only: Has received prior radiation therapy (RT) to index&#xD;
               site or has been deemed to be not eligible for RT&#xD;
  &#xD;
            -  LA unresectable cSCC cohort only: Has received prior systemic therapy for curative&#xD;
               intent are eligible regardless of regimen&#xD;
  &#xD;
            -  Has a life expectancy of greater than 3 months&#xD;
  &#xD;
            -  Must provide archival tumor tissue sample or newly obtained core or excisional biopsy&#xD;
               of a tumor lesion not previously irradiated&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has cSCC that can be cured with surgical resection, radiotherapy, or with a&#xD;
               combination of surgery and radiotherapy.&#xD;
  &#xD;
            -  Has any other histologic type of skin cancer other than invasive squamous cell&#xD;
               carcinoma as the primary disease under study&#xD;
  &#xD;
            -  Has received prior systemic anticancer therapy including investigation agents within 4&#xD;
               weeks before allocation&#xD;
  &#xD;
            -  Has not adequately recovered from major surgery or has ongoing surgical complications&#xD;
  &#xD;
            -  Received prior radiotherapy within 2 weeks of study intervention, or had&#xD;
               radiation-related toxicities, requiring corticosteroids&#xD;
  &#xD;
            -  Received a live or live-attenuated vaccine within 30 days before the first dose of&#xD;
               study intervention&#xD;
  &#xD;
            -  Known additional malignancy that is progressing or has required active treatment&#xD;
               within the past 2 years&#xD;
  &#xD;
            -  Has an ongoing active infection requiring systemic therapy&#xD;
  &#xD;
            -  Has a history of human immunodeficiency virus (HIV) infection&#xD;
  &#xD;
            -  Has an active autoimmune disease that has required systemic treatment in past 2 years&#xD;
  &#xD;
            -  Has history of allogenic tissue/organ transplant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Medical Director</last_name>
      <role>Study Director</role>
      <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
    </overall_official>
    <link>
      <url>https://www.merckclinicaltrials.com/</url>
      <description>Merck Clinical Trials Information</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Programmed Cell Death-1 (PD1, PD-1)</keyword>
    <keyword>Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)</keyword>
    <keyword>Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</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>
    <!-- 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/NCT06041802
  org study id: 3475A-E39
  secondary id: MK-3475A-E39
  secondary id: jRCT2041230074
  nct id: NCT06041802
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy, safety, and tolerability of
        subcutaneous (SC) MK-3475A in Japanese participants with recurrent or metastatic cutaneous
        squamous cell carcinoma or locally advanced unresectable cSCC. The primary hypothesis is that
        MK-3475A will result in greater than 10% objective response rate (ORR) per Response
        Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded
        Independent Central Review (BICR).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective Response Rate (ORR)
  time frame: Up to approximately 40 months
  description: ORR is 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 experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
  measure: Duration of Response (DOR)
  time frame: Up to approximately 40 months
  description: For participants who demonstrate CR (disappearance of all target lesions) or 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 CR or PR 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 BICR will be presented.
  measure: Disease Control Rate (DCR)
  time frame: Up to approximately 40 months
  description: DCR is defined, per RECIST 1.1, as the percentage of participants who demonstrate a confirmed CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [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.]).The DCR as assessed by BICR will be presented.
  measure: Overall Survival (OS)
  time frame: Up to approximately 40 months
  description: OS is defined as the time from first dose of study treatment to death due to any cause.
  measure: Number of Participants who Experience an Adverse Event (AE)
  time frame: Up to approximately 30 months
  description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience at least one AE will be reported.
  measure: Number of Participants who Discontinue Due to an AE
  time frame: Up to approximately 27 months
  description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
  arm group label: MK-3475A
  arm group type: Experimental
  description: Participants will receive MK-3475A subcutaneously for up to 18 administrations.
  intervention type: Biological
  intervention name: MK-3475A
  description: MK-3475A is a fixed-dose formulation of pembrolizumab and MK-5180 for SC administration.
  arm group label: MK-3475A
  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
  url: https://www.merckclinicaltrials.com/
  description: Merck Clinical Trials Information
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Pembrolizumab
  sharing ipd: Yes
  ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
  ipd url: http://engagezone.msd.com/ds_documentation.php