<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/NCT03277352</url>
  </required_header>
  <id_info>
    <org_study_id>INCAGN 1876-202</org_study_id>
    <nct_id>NCT03277352</nct_id>
  </id_info>
  <brief_title>INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies</brief_title>
  <official_title>A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Biosciences International Sàrl</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyte Corporation</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 determine the safety, tolerability, and efficacy of&#xD;
      INCAGN01876 when given in combination with immune therapies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated due to emergent data from another study and unrelated to safety.&#xD;
  </why_stopped>
  <start_date type="Actual">November 21, 2017</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</primary_completion_date>
  <phase>Phase 1/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>Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]</measure>
    <time_frame>Screening through 60 days after end of treatment, up to approximately 18 months</time_frame>
    <description>A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST</measure>
    <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months</time_frame>
    <description>Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1</measure>
    <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months</time_frame>
    <description>Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 1 &amp; Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST</measure>
    <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.</time_frame>
    <description>Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 &amp; Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST</measure>
    <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months</time_frame>
    <description>Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 &amp; Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST</measure>
    <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months</time_frame>
    <description>Defined as time from first report of SD or better until disease progression or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 &amp; Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST</measure>
    <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months</time_frame>
    <description>Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 &amp; Phase 2: Overall Survival</measure>
    <time_frame>At 1 year and 2 years.</time_frame>
    <description>Defined as the time from the start of combination therapy until death due to any cause.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Advanced Malignancies</condition>
  <condition>Metastatic Cancer</condition>
  <arm_group>
    <arm_group_label>INCAGN01876 + Pembrolizumab + Epacadostat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>INCAGN01876 in combination with pembrolizumab and epacadostat</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INCAGN01876</intervention_name>
    <description>In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.</description>
    <arm_group_label>INCAGN01876 + Pembrolizumab + Epacadostat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epacadostat</intervention_name>
    <description>Epacadostat will be self-administered orally at the protocol-defined dose.</description>
    <arm_group_label>INCAGN01876 + Pembrolizumab + Epacadostat</arm_group_label>
    <other_name>INCB024360</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Pembrolizumab will be administered IV at the protocol-defined dose.</description>
    <arm_group_label>INCAGN01876 + Pembrolizumab + Epacadostat</arm_group_label>
    <other_name>Keytruda®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Locally advanced or metastatic disease; locally advanced disease must not be amenable&#xD;
             to resection with curative intent.&#xD;
&#xD;
          -  Phase 1: Subjects with advanced or metastatic solid tumors.&#xD;
&#xD;
          -  Phase 1: Subjects who have disease progression after treatment with available&#xD;
             therapies.&#xD;
&#xD;
          -  Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma.&#xD;
&#xD;
          -  Presence of measurable disease based on RECIST v1.1.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status of 0 or 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Laboratory and medical history parameters not within the Protocol-defined range&#xD;
&#xD;
          -  Prior treatment with any tumor necrosis factor super family agonist.&#xD;
&#xD;
          -  Receipt of anticancer medications or investigational drugs within protocol-defined&#xD;
             intervals before the first administration of study drug.&#xD;
&#xD;
          -  Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.&#xD;
&#xD;
          -  Active autoimmune disease.&#xD;
&#xD;
          -  Known active central nervous system metastases and/or carcinomatous meningitis.&#xD;
&#xD;
          -  Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.&#xD;
&#xD;
          -  Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.&#xD;
&#xD;
          -  Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).&#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>John N. Janik, MD</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Angeles Clinic and Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <results_first_submitted>July 1, 2021</results_first_submitted>
  <results_first_submitted_qc>July 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 22, 2021</results_first_posted>
  <last_update_submitted>July 1, 2021</last_update_submitted>
  <last_update_submitted_qc>July 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cervical cancer</keyword>
  <keyword>endometrial cancer</keyword>
  <keyword>gastric cancer (including stomach and gastroesophageal junction (GEJ))</keyword>
  <keyword>esophageal cancer</keyword>
  <keyword>hepatocellular carcinoma (HCC)</keyword>
  <keyword>melanoma (mucosal or cutaneous)</keyword>
  <keyword>Merkel cell carcinoma</keyword>
  <keyword>mesothelioma</keyword>
  <keyword>microsatellite instability-high (MSI-H)</keyword>
  <keyword>solid tumors</keyword>
  <keyword>non-small cell lung cancer (NSCLC)</keyword>
  <keyword>ovarian cancer</keyword>
  <keyword>squamous cell carcinoma of the head and neck (SCCHN)</keyword>
  <keyword>small cell lung cancer (SCLC)</keyword>
  <keyword>renal cell carcinoma (RCC)</keyword>
  <keyword>triple-negative breast cancer (TNBC)</keyword>
  <keyword>urothelial carcinoma</keyword>
  <keyword>glucocorticoid-induced tumor necrosis factor receptor (GITR)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03277352/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03277352/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 2 different sites in USA. A total of 10 participants were enrolled in the study.</recruitment_details>
      <pre_assignment_details>A total of 10 participants were screened and enrolled in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>INCAGN01876 + Pembrolizumab + Epacadostat</title>
          <description>INCAGN01876 in combination with pembrolizumab and epacadostat</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </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="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Terminated By Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Full Analysis Set (FAS) includes all subjects enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
      <group_list>
        <group group_id="B1">
          <title>INCAGN01876 + Pembrolizumab + Epacadostat</title>
          <description>INCAGN01876 in combination with pembrolizumab and epacadostat</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </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="64.2" spread="13.73"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White/Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]</title>
        <description>A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.</description>
        <time_frame>Screening through 60 days after end of treatment, up to approximately 18 months</time_frame>
        <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
        <group_list>
          <group group_id="O1">
            <title>INCAGN01876 + Pembrolizumab + Epacadostat</title>
            <description>INCAGN01876 in combination with pembrolizumab and epacadostat</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]</title>
          <description>A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.</description>
          <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST</title>
        <description>Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.</description>
        <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months</time_frame>
        <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
        <group_list>
          <group group_id="O1">
            <title>INCAGN01876 + Pembrolizumab + Epacadostat</title>
            <description>INCAGN01876 in combination with pembrolizumab and epacadostat</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST</title>
          <description>Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.</description>
          <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1</title>
        <description>Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1</description>
        <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months</time_frame>
        <population>The study was terminated early and no participants enrolled in Phase 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>INCAGN01876 + Pembrolizumab + Epacadostat</title>
            <description>INCAGN01876 in combination with pembrolizumab and epacadostat</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1</title>
          <description>Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1</description>
          <population>The study was terminated early and no participants enrolled in Phase 2 of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1 &amp; Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST</title>
        <description>Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.</description>
        <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.</time_frame>
        <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
        <group_list>
          <group group_id="O1">
            <title>INCAGN01876 + Pembrolizumab + Epacadostat</title>
            <description>INCAGN01876 in combination with pembrolizumab and epacadostat</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 &amp; Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST</title>
          <description>Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.</description>
          <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1 &amp; Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST</title>
        <description>Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.</description>
        <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months</time_frame>
        <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
        <group_list>
          <group group_id="O1">
            <title>INCAGN01876 + Pembrolizumab + Epacadostat</title>
            <description>INCAGN01876 in combination with pembrolizumab and epacadostat</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 &amp; Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST</title>
          <description>Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.</description>
          <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="273" upper_limit="NA">The median duration of response is not estimable if less than half of the participants had an event (progression or death).</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1 &amp; Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST</title>
        <description>Defined as time from first report of SD or better until disease progression or death from any cause.</description>
        <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months</time_frame>
        <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
        <group_list>
          <group group_id="O1">
            <title>INCAGN01876 + Pembrolizumab + Epacadostat</title>
            <description>INCAGN01876 in combination with pembrolizumab and epacadostat</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 &amp; Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST</title>
          <description>Defined as time from first report of SD or better until disease progression or death from any cause.</description>
          <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>mRECIST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="525" upper_limit="NA">The median duration of response is not estimable if less than half of the participants had an event (progression or death).</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RECIST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="525" lower_limit="92" upper_limit="NA">The number of responders is not enough to estimate a standard error for the confidence interval.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1 &amp; Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST</title>
        <description>Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.</description>
        <time_frame>Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months</time_frame>
        <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
        <group_list>
          <group group_id="O1">
            <title>INCAGN01876 + Pembrolizumab + Epacadostat</title>
            <description>INCAGN01876 in combination with pembrolizumab and epacadostat</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 &amp; Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST</title>
          <description>Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.</description>
          <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>mRECIST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.36" lower_limit="2.05" upper_limit="NA">The number of responders is not enough to estimate a standard error for the confidence interval.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RECIST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.20" lower_limit="0.73" upper_limit="NA">The number of responders is not enough to estimate a standard error for the confidence interval.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1 &amp; Phase 2: Overall Survival</title>
        <description>Defined as the time from the start of combination therapy until death due to any cause.</description>
        <time_frame>At 1 year and 2 years.</time_frame>
        <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
        <group_list>
          <group group_id="O1">
            <title>INCAGN01876 + Pembrolizumab + Epacadostat</title>
            <description>INCAGN01876 in combination with pembrolizumab and epacadostat</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 &amp; Phase 2: Overall Survival</title>
          <description>Defined as the time from the start of combination therapy until death due to any cause.</description>
          <population>The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.59" lower_limit="16.76" upper_limit="NA">upper limit is not estimable</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 18 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID</title>
          <description>INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID</description>
        </group>
        <group group_id="E2">
          <title>Total</title>
          <description>Total</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20</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="4" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20</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="10" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="10"/>
              </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="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Macular hole</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hydrogen breath test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperchloraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </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="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lung infiltration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </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>Clinical Study Agreement</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Incyte Corporation</organization>
      <phone>1-855-463-3463</phone>
      <email>medinfo@incyte.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/NCT03277352
org study id: INCAGN 1876-202
nct id: NCT03277352
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine the safety, tolerability, and efficacy of
      INCAGN01876 when given in combination with immune therapies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
time frame: Screening through 60 days after end of treatment, up to approximately 18 months
description: A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
measure: Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST
time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
description: Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.
measure: Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1
time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
description: Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1
measure: Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST
time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.
description: Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.
measure: Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST
time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
description: Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.
measure: Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST
time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
description: Defined as time from first report of SD or better until disease progression or death from any cause.
measure: Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST
time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
description: Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.
measure: Phase 1 & Phase 2: Overall Survival
time frame: At 1 year and 2 years.
description: Defined as the time from the start of combination therapy until death due to any cause.
arm group label: INCAGN01876 + Pembrolizumab + Epacadostat
arm group type: Experimental
description: INCAGN01876 in combination with pembrolizumab and epacadostat
intervention type: Drug
intervention name: INCAGN01876
description: In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
arm group label: INCAGN01876 + Pembrolizumab + Epacadostat
intervention type: Drug
intervention name: Epacadostat
description: Epacadostat will be self-administered orally at the protocol-defined dose.
arm group label: INCAGN01876 + Pembrolizumab + Epacadostat
other name: INCB024360
intervention type: Drug
intervention name: Pembrolizumab
description: Pembrolizumab will be administered IV at the protocol-defined dose.
arm group label: INCAGN01876 + Pembrolizumab + Epacadostat
other name: Keytruda®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John N. Janik, MD
role: Study Director
affiliation: Incyte Corporation
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Pembrolizumab
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 