<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/NCT04463771</url>
  </required_header>
  <id_info>
    <org_study_id>INCMGA 0012-204</org_study_id>
    <nct_id>NCT04463771</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.</brief_title>
  <acronym>POD1UM-204</acronym>
  <official_title>An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GOG Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Network of Gynaecological Oncological Trial Groups (ENGOT)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in&#xD;
      participants who have advanced or metastatic endometrial cancer that has progressed on or&#xD;
      after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in&#xD;
      combination with other immunotherapy or targeted agents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 26, 2021</start_date>
  <completion_date type="Anticipated">June 22, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 25, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Group A - Objective Response Rate</measure>
    <time_frame>up to 2.5 years</time_frame>
    <description>Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Group A -Duration of Response</measure>
    <time_frame>up to 2.5 years</time_frame>
    <description>Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group A - Disease Control Rate</measure>
    <time_frame>up to 2.5 years</time_frame>
    <description>Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group A - Overall Survival</measure>
    <time_frame>up to 3.5 years</time_frame>
    <description>Defined as the time from the first dose of study treatment until death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group A - Progression Free Survival</measure>
    <time_frame>up to 3.5 years</time_frame>
    <description>Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group B -Duration of Response</measure>
    <time_frame>up to 2.5 years</time_frame>
    <description>Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group B - Disease Control Rate</measure>
    <time_frame>up to 2.5 years</time_frame>
    <description>Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group B - Overall Survival</measure>
    <time_frame>up to 3.5 years</time_frame>
    <description>Defined as the time from the first dose of study treatment until death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Groups B - Objective Response Rate</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group B - Progression Free Survival</measure>
    <time_frame>up to 3.5 years</time_frame>
    <description>Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Groups C, D, E and F - Objective Response Rate</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment-Related Adverse Events</measure>
    <time_frame>up to 4 years</time_frame>
    <description>Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>Group A - retifanlimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - retifanlimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C - retifanlimab + epacadostat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D - retifanlimab + pemigatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group E - retifanlimab + epacadostat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group F - retifanlimab + INCAGN02385 and INCAGN02390</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>retifanlimab</intervention_name>
    <description>INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.</description>
    <arm_group_label>Group A - retifanlimab</arm_group_label>
    <arm_group_label>Group B - retifanlimab</arm_group_label>
    <arm_group_label>Group C - retifanlimab + epacadostat</arm_group_label>
    <arm_group_label>Group D - retifanlimab + pemigatinib</arm_group_label>
    <arm_group_label>Group E - retifanlimab + epacadostat</arm_group_label>
    <other_name>INCMGA00012</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>epacadostat</intervention_name>
    <description>epacadostat will be administered orally BID.</description>
    <arm_group_label>Group C - retifanlimab + epacadostat</arm_group_label>
    <arm_group_label>Group E - retifanlimab + epacadostat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pemigatinib</intervention_name>
    <description>pemigatinib will be administered orally QD.</description>
    <arm_group_label>Group D - retifanlimab + pemigatinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INCAGN02385</intervention_name>
    <description>INCAGN2385 will be administered every 2 weeks</description>
    <arm_group_label>Group F - retifanlimab + INCAGN02385 and INCAGN02390</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INCAGN02390</intervention_name>
    <description>INCAGN2390 will be administered every 2 weeks</description>
    <arm_group_label>Group F - retifanlimab + INCAGN02385 and INCAGN02390</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to comprehend and willingness to sign a written ICF for the study. Note for&#xD;
             Germany: This excludes individuals who are housed in an institution due to official or&#xD;
             court order Women 18 years of age or older (or as applicable per local country&#xD;
             requirements).&#xD;
&#xD;
          -  Histologically confirmed diagnosis of advanced or metastatic endometrial cancer with&#xD;
             disease progression on or after treatment with at least 1 platinum-containing regimen&#xD;
             for advanced or metastatic disease.&#xD;
&#xD;
          -  Groups A, B, and E: Have not been previously treated with a PD-(L)1 inhibitor.&#xD;
&#xD;
          -  Group A only: Tumor tissue tested as MSI-High&#xD;
&#xD;
          -  Group B only: Tumor tissue tested as deficient MMR or an ultra-mutated POLE tumor.&#xD;
&#xD;
          -  Group D only: Tumor tissue tested as having an FGFR 1,2,3 mutation or alteration&#xD;
             characterized as per protocol.&#xD;
&#xD;
          -  Group E: Tumor tissue tested as MSS and PD-L1 positive.&#xD;
&#xD;
          -  Group F: Radiological evidence of disease progression on or after prior PD (L)1&#xD;
             therapy and Tumor tissue tested as MSI-H&#xD;
&#xD;
          -  Must have at least 1 measurable tumor lesion per RECIST v1.1.&#xD;
&#xD;
          -  Willing to provide tumor tissue sample (fresh or archived).&#xD;
&#xD;
          -  ECOG performance status 0 to 1.&#xD;
&#xD;
          -  Willingness to avoid pregnancy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Group A, B and E only: Histologically confirmed diagnosis of carcinosarcoma of the&#xD;
             uterus.&#xD;
&#xD;
          -  Histologically confirmed diagnosis of sarcoma of the uterus.&#xD;
&#xD;
          -  Has disease eligible for potentially curative treatment.&#xD;
&#xD;
          -  Receipt of anticancer therapy within 28 days of the first administration of study&#xD;
             treatment, with the exception of localized radiotherapy.&#xD;
&#xD;
          -  Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline unless&#xD;
             approved by the medical monitor.&#xD;
&#xD;
          -  Groups C, D and F (combinations): limiting immune-related toxicity during prior&#xD;
             checkpoint inhibitor therapy.&#xD;
&#xD;
          -  Group F only: Previous treatment with LAG-# or TIM-3 therapy or lenvatinib; multiple&#xD;
             metastases that achieved mixed tumor response to prior anti-PD-(L)1 therapy&#xD;
&#xD;
          -  Has an active autoimmune disease requiring systemic immunosuppression with&#xD;
             corticosteroids (&gt; 10 mg/day of prednisone or equivalent) or immunosuppressive drugs&#xD;
             within 14 days before the first dose of study treatment.&#xD;
&#xD;
          -  Receiving chronic systemic steroids (&gt; 10 mg/day of prednisone or equivalent):&#xD;
&#xD;
          -  Known active CNS metastases and/or carcinomatous meningitis.&#xD;
&#xD;
          -  Has known active hepatitis B or C.&#xD;
&#xD;
          -  Has received a live vaccine within 28 days of the planned start of study treatment.&#xD;
&#xD;
          -  Evidence of interstitial lung disease or active, noninfectious pneumonitis.&#xD;
&#xD;
          -  Participants who are known to be HIV-positive with some protocol exceptions.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Cornfield</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Incyte Corporation Call Center (US)</last_name>
    <phone>1.855.463.3463</phone>
    <email>medinfo@incyte.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Incyte Corporation Call Center (ex-US)</last_name>
    <phone>+800 00027423</phone>
    <email>eumedinfo@incyte.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Alaska Womens Cancer Care Akwcc</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Honorhealth</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology Associates</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85711</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCLA Medical Hematology &amp; Oncology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Olive View Med Ctr</name>
      <address>
        <city>Sylmar</city>
        <state>California</state>
        <zip>91342</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Broward Health Medical Center</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center Comprehensive Cancer Center</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Advent Health Medical Group-Orlando 2501</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612-9497</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Georgia Cancer Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Barbara Ann Karmanos Cancer Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology-Maplewood</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Midwest Cancer Care</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Billings Clinic Cancer Center</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>New Mexico Cancer Care Alliance</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Columbia University Hervert Irving Comprehensive Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of North Carolina At Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center Division of Gynecologic Oncology</name>
      <address>
        <city>Hilliard</city>
        <state>Ohio</state>
        <zip>43026</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Willamette Valley Cancer Institute</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401-8122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Tyler</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Austin Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104-3902</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology the Woodlands</name>
      <address>
        <city>Shenandoah</city>
        <state>Texas</state>
        <zip>77380</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>O.L.V Ziekenhuis</name>
      <address>
        <city>Aalst</city>
        <zip>09300</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>01000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Gent</city>
        <zip>09000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaire Ziekenhuis Leuven - Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>03000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Liege - Sart Tilman</name>
      <address>
        <city>Liège</city>
        <zip>04000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chu Ucl Namur de Saint Elisabeth</name>
      <address>
        <city>Namur</city>
        <zip>05000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Affiliated Drum Tower Hospital of Nanjing University</name>
      <address>
        <city>Nanjing</city>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Chu Besancon Hospital Jean Minjoz</name>
      <address>
        <city>Besancon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie</name>
      <address>
        <city>Bordeaux Cedex</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Cochin Cancerologie</name>
      <address>
        <city>Paris</city>
        <zip>75006</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie</name>
      <address>
        <city>Plérin</city>
        <zip>22190</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau</name>
      <address>
        <city>Saint Herblain</city>
        <zip>44800</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif Cedex</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>High Technology Hospital Medcenter</name>
      <address>
        <city>Batumi</city>
        <zip>06000</zip>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jsc Evex Hospitals</name>
      <address>
        <city>Kutaisi</city>
        <zip>04600</zip>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Todua Clinic, Llc</name>
      <address>
        <city>Tbilisi</city>
        <zip>00112</zip>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Caucasus Medical Centre Llc</name>
      <address>
        <city>Tbilisi</city>
        <zip>00186</zip>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ltd Innova</name>
      <address>
        <city>Tbilisi</city>
        <zip>00186</zip>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Multiprofile Clinic Consilium Medulla Llc</name>
      <address>
        <city>Tbilisi</city>
        <zip>00186</zip>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Charite - Campus Virchow-Klinikum</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University Clinic Carl Gustav Carus Technical University Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Kassel Gmbh</name>
      <address>
        <city>Kassel</city>
        <zip>34125</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Universitarsfrauenklinik Ulm</name>
      <address>
        <city>ULM</city>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alexandra General Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital of West Attica - Attikon</name>
      <address>
        <city>Athens</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hygeia Hospital</name>
      <address>
        <city>Marousi</city>
        <zip>15123</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Euromedica General Clinic of Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54645</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero Di Summa Antonio Perrino</name>
      <address>
        <city>Brindisi</city>
        <zip>72100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori</name>
      <address>
        <city>Meldola</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>European Institute of Oncology</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori Irccs Fondazione Pascale</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Iov - Istituto Oncologico Veneto Irccs</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli Irccs</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria Ca Foncello</name>
      <address>
        <city>Treviso</city>
        <zip>31100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>China</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometrial Carcinoma</keyword>
  <keyword>Endometrium Cancer</keyword>
  <keyword>Neoplasms Endometrial</keyword>
  <keyword>Advanced</keyword>
  <keyword>Metastatic</keyword>
  <keyword>PD-1</keyword>
  <keyword>PD-L1</keyword>
  <keyword>retifanlimab</keyword>
  <keyword>INCMGA0012</keyword>
  <keyword>INCAGN02385</keyword>
  <keyword>INCAGN02390</keyword>
  <keyword>PODIUM</keyword>
  <keyword>LAG-3</keyword>
  <keyword>TIM-3</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.</ipd_time_frame>
    <ipd_access_criteria>Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://www.incyte.com/our-company/compliance-and-transparency</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04463771
org study id: INCMGA 0012-204
nct id: NCT04463771
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in
      participants who have advanced or metastatic endometrial cancer that has progressed on or
      after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in
      combination with other immunotherapy or targeted agents.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Group A - Objective Response Rate
time frame: up to 2.5 years
description: Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
measure: Group A -Duration of Response
time frame: up to 2.5 years
description: Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.
measure: Group A - Disease Control Rate
time frame: up to 2.5 years
description: Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.
measure: Group A - Overall Survival
time frame: up to 3.5 years
description: Defined as the time from the first dose of study treatment until death due to any cause.
measure: Group A - Progression Free Survival
time frame: up to 3.5 years
description: Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.
measure: Group B -Duration of Response
time frame: up to 2.5 years
description: Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.
measure: Group B - Disease Control Rate
time frame: up to 2.5 years
description: Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.
measure: Group B - Overall Survival
time frame: up to 3.5 years
description: Defined as the time from the first dose of study treatment until death due to any cause.
measure: Groups B - Objective Response Rate
time frame: up to 2 years
description: Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
measure: Group B - Progression Free Survival
time frame: up to 3.5 years
description: Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.
measure: Groups C, D, E and F - Objective Response Rate
time frame: up to 2 years
description: Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
measure: Number of Treatment-Related Adverse Events
time frame: up to 4 years
description: Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
arm group label: Group A - retifanlimab
arm group type: Experimental
description: Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
arm group label: Group B - retifanlimab
arm group type: Experimental
description: Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
arm group label: Group C - retifanlimab + epacadostat
arm group type: Experimental
description: Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)
arm group label: Group D - retifanlimab + pemigatinib
arm group type: Experimental
description: Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)
arm group label: Group E - retifanlimab + epacadostat
arm group type: Experimental
description: Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat
arm group label: Group F - retifanlimab + INCAGN02385 and INCAGN02390
arm group type: Experimental
description: Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously
intervention type: Drug
intervention name: retifanlimab
description: INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
arm group label: Group A - retifanlimab
arm group label: Group B - retifanlimab
arm group label: Group C - retifanlimab + epacadostat
arm group label: Group D - retifanlimab + pemigatinib
arm group label: Group E - retifanlimab + epacadostat
other name: INCMGA00012
intervention type: Drug
intervention name: epacadostat
description: epacadostat will be administered orally BID.
arm group label: Group C - retifanlimab + epacadostat
arm group label: Group E - retifanlimab + epacadostat
intervention type: Drug
intervention name: pemigatinib
description: pemigatinib will be administered orally QD.
arm group label: Group D - retifanlimab + pemigatinib
intervention type: Drug
intervention name: INCAGN02385
description: INCAGN2385 will be administered every 2 weeks
arm group label: Group F - retifanlimab + INCAGN02385 and INCAGN02390
intervention type: Drug
intervention name: INCAGN02390
description: INCAGN2390 will be administered every 2 weeks
arm group label: Group F - retifanlimab + INCAGN02385 and INCAGN02390
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Cornfield
role: Study Director
affiliation: Incyte Corporation
last name: Incyte Corporation Call Center (US)
phone: 1.855.463.3463
email: medinfo@incyte.com
last name: Incyte Corporation Call Center (ex-US)
phone: +800 00027423
email: eumedinfo@incyte.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Belgium
country: China
country: France
country: Georgia
country: Germany
country: Greece
country: Italy
country: United States
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
sharing ipd: Yes
ipd description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
ipd access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
ipd url: https://www.incyte.com/our-company/compliance-and-transparency