<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/NCT03002376</url>
  </required_header>
  <id_info>
    <org_study_id>R2810-ONC-1606</org_study_id>
    <secondary_id>2016-002755-16</secondary_id>
    <nct_id>NCT03002376</nct_id>
  </id_info>
  <brief_title>An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)</brief_title>
  <official_title>An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Indicators of Clinical Response in Immunomodulatory Treatment-naïve Unresectable Stage III/IV Melanoma Patients Receiving REGN2810 (Anti-PD-1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Regeneron Pharmaceuticals</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>
      This study is being conducted to compare the relationship of patient response to treatment to&#xD;
      changes in tumor environment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2017</start_date>
  <completion_date type="Actual">March 19, 2020</completion_date>
  <primary_completion_date type="Actual">March 5, 2019</primary_completion_date>
  <phase>Phase 1</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>Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline</measure>
    <time_frame>Baseline up to week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810</measure>
    <time_frame>Baseline up to week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Event (AEs) in patients treated with REGN2810</measure>
    <time_frame>Baseline through treatment with REGN2810 (up to 48 weeks) and follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>REGN2810 serum concentrations</measure>
    <time_frame>Baseline up to 6 weeks following last dose of REGN2810</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-REGN2810 antibody levels</measure>
    <time_frame>Baseline up to 6 weeks following last dose of REGN2810</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The progression-free survival (PFS) in patients treated with REGN2810</measure>
    <time_frame>Baseline up to 6 weeks following last dose of REGN2810</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The overall response rate in patients treated with REGN2810</measure>
    <time_frame>Baseline up to 6 weeks following last dose of REGN2810</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>REGN2810</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>REGN2810 treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>REGN2810</intervention_name>
    <description>REGN2810 treatment</description>
    <arm_group_label>REGN2810</arm_group_label>
    <other_name>cemiplimab</other_name>
    <other_name>Libtayo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of stage III (unresectable) or stage IV cutaneous&#xD;
             melanoma (non-acral lentiginous) with at least 1 lesion that is measurable by RECIST&#xD;
             1.1 criteria and accessible for biopsies&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1&#xD;
&#xD;
          -  Adequate hepatic function&#xD;
&#xD;
          -  Adequate renal function&#xD;
&#xD;
          -  Adequate bone marrow function&#xD;
&#xD;
          -  Willing and able to comply with clinic visits and study-related procedures&#xD;
&#xD;
          -  Provide signed informed consent&#xD;
&#xD;
          -  Able to understand and complete study-related questionnaires&#xD;
&#xD;
          -  Anticipated life expectancy &gt;12 weeks&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Ongoing or recent (within 5 years) evidence of significant autoimmune disease that&#xD;
             required treatment with systemic immunosuppressive treatments, which may suggest risk&#xD;
             for immune-related adverse events (irAEs).&#xD;
&#xD;
          -  Prior treatment with an agent that blocks the programmed death-1/ programmed&#xD;
             death-ligand 1 (PD-1/PD-L1 pathway)&#xD;
&#xD;
          -  Prior treatment with other immune modulating anti-cancer agents, except for remote&#xD;
             treatment (&gt;6 months) in adjuvant setting.&#xD;
&#xD;
          -  Untreated or active brain metastases or spinal cord compression&#xD;
&#xD;
          -  Immunosuppressive corticosteroid doses (&gt;10 mg prednisone daily or equivalent) within&#xD;
             4 weeks prior to the first dose of REGN2810&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria will apply&#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>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital-Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud University Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Medical Academy</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's Hospital and St. Thomas NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Churchill Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>0X3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Serbia</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>April 16, 2020</last_update_submitted>
  <last_update_submitted_qc>April 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Cemiplimab</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03002376
org study id: R2810-ONC-1606
secondary id: 2016-002755-16
nct id: NCT03002376
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is being conducted to compare the relationship of patient response to treatment to
      changes in tumor environment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline
time frame: Baseline up to week 24
measure: Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810
time frame: Baseline up to week 24
measure: Incidence of Adverse Event (AEs) in patients treated with REGN2810
time frame: Baseline through treatment with REGN2810 (up to 48 weeks) and follow up
measure: REGN2810 serum concentrations
time frame: Baseline up to 6 weeks following last dose of REGN2810
measure: Anti-REGN2810 antibody levels
time frame: Baseline up to 6 weeks following last dose of REGN2810
measure: The progression-free survival (PFS) in patients treated with REGN2810
time frame: Baseline up to 6 weeks following last dose of REGN2810
measure: The overall response rate in patients treated with REGN2810
time frame: Baseline up to 6 weeks following last dose of REGN2810
arm group label: REGN2810
arm group type: Experimental
description: REGN2810 treatment
intervention type: Drug
intervention name: REGN2810
description: REGN2810 treatment
arm group label: REGN2810
other name: cemiplimab
other name: Libtayo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
country: Netherlands
country: Serbia
country: United Kingdom
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Cemiplimab