NCT04463771CompletedPhase 2
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.
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)
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 206 (actual)
- First submitted
- 6 Jul 2020
- Start date
- 26 Jan 2021
- Primary completion date
- 29 May 2026
- Lead sponsor
- Incyte Corporation
- Diseases
- Endometrial cancer
- NCT number
- NCT04463771
- EU CT number
- 2022-502600-79-00
- EudraCT number
- 2020-000496-20
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 206
- From 26 Jan 2021 to the primary completion date, 29 May 2026
- 63 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of anticancer therapy within 28 days of the first administration of study treatment, with the exception of localized radiotherapy.
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline unless approved by the medical monitor.
- Groups C, D and F (combinations): limiting immune-related toxicity during prior checkpoint inhibitor therapy.
- Group F only: Previous treatment with LAG-# or TIM-3 therapy or lenvatinib; multiple metastases that achieved mixed tumor response to prior anti-PD-(L)1 therapy
- Has an active autoimmune disease requiring systemic immunosuppression with corticosteroids (\> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 14 days before the first dose of study treatment.
- Receiving chronic systemic steroids (\> 10 mg/day of prednisone or equivalent):
- Has received a live vaccine within 28 days of the planned start of study treatment.
Other illness
- Has disease eligible for potentially curative treatment.
- Has known active hepatitis B or C.
- Evidence of interstitial lung disease or active, noninfectious pneumonitis.
- Participants who are known to be HIV-positive with some protocol exceptions.
Other
- Group A, B and E only: Histologically confirmed diagnosis of carcinosarcoma of the uterus.
- Histologically confirmed diagnosis of sarcoma of the uterus.
- Known active CNS metastases and/or carcinomatous meningitis.
Who the study is looking for
- Ability to comprehend and willingness to sign a written ICF for the study. Note for Germany: This excludes individuals who are housed in an institution due to official or court order Women 18 years of age or older (or as applicable per local country requirements).
- Histologically confirmed diagnosis of advanced or metastatic endometrial cancer with disease progression on or after treatment with at least 1 platinum-containing regimen for advanced or metastatic disease.
- Groups A, B, and E: Have not been previously treated with a PD-(L)1 inhibitor.
- Group A only: Tumor tissue tested as MSI-High
- Group B only: Tumor tissue tested as deficient MMR or an ultra-mutated POLE tumor.
- Group D only: Tumor tissue tested as having an FGFR 1,2,3 mutation or alteration characterized as per protocol.
- Group E: Tumor tissue tested as MSS and PD-L1 positive.
- Group F: Radiological evidence of disease progression on or after prior PD (L)1 therapy and Tumor tissue tested as MSI-H
- Must have at least 1 measurable tumor lesion per RECIST v1.1.
- Willing to provide tumor tissue sample (fresh or archived).
- ECOG performance status 0 to 1.
- Willingness to avoid pregnancy.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (63)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Completed |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Namur | Belgium | Completed |
| Charité Campus Virchow-Klinikum Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| University Clinic Carl Gustav Carus Technical University Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Klinikum Kassel GmbH Coordinator of this site? Confirm its status | Kassel | Germany | Unknown status |
| Universitarsfrauenklinik Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Besancon University Hospital Center Coordinator of this site? Confirm its status | Besancon Cedex | France | Completed |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Hôpital Privé des Côtes d'Armor Coordinator of this site? Confirm its status | Plérin | France | Completed |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | St Herblain | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| High Technology Hospital Medcenter Coordinator of this site? Confirm its status | Batumi | Georgia | Unknown status |
| Jsc Evex Hospitals Coordinator of this site? Confirm its status | Kutaisi | Georgia | Unknown status |
| Multiprofile Clinic Consilium Medulla Llc Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| INNOVA Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Caucasus Medical Centre LLC Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Todua Clinic LLC Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Coordinator of this site? Confirm its status | Maroussi | Greece | Completed |
| Euromedica General Clinic of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Completed |
| European Institute Of Oncology S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana Coordinator of this site? Confirm its status | Treviso | Italy | Completed |
| New Mexico Cancer Care Alliance Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Alaska Womens Cancer Care Akwcc Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Georgia Cancer Center Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Texas Oncology-Austin Center Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Billings Clinic Cancer Center Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Minnesota Oncology-Maplewood Coordinator of this site? Confirm its status | Coon Rapids | United States | Unknown status |
| Barbara Ann Karmanos Cancer Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Willamette Valley Cancer Institute Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Broward Health Medical Center Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Texas Oncology-Fort Worth South Henderson Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| The Ohio State University Wexner Medical Center Division of Gynecologic Oncology Coordinator of this site? Confirm its status | Hilliard | United States | Unknown status |
| Midwest Cancer Care Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| UCLA Medical Hematology & Oncology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Miami Cancer Institute Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Mount Sinai Medical Center Comprehensive Cancer Center Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Laura & Isaac Perlmutter Cancer Ctr Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Advent Health Medical Group-Orlando 2501 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| HonorHealth Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Texas Oncology - San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Texas Oncology the Woodlands Coordinator of this site? Confirm its status | Shenandoah | United States | Unknown status |
| Texas Oncology-Tyler Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Olive View Med Ctr Coordinator of this site? Confirm its status | Sylmar | United States | Unknown status |
| H. Lee Moffitt Cancer Center and Research Institute Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Arizona Oncology Associates Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.