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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
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

Full criteria on ClinicalTrials.gov

Sites (63)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Jules Bordet
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AnderlechtBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
CHU de Liège
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LiègeBelgiumCompleted
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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NamurBelgiumCompleted
Charité Campus Virchow-Klinikum
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BerlinGermanyUnknown status
University Clinic Carl Gustav Carus Technical University Dresden
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DresdenGermanyUnknown status
Klinikum Kassel GmbH
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KasselGermanyUnknown status
Universitarsfrauenklinik Ulm
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UlmGermanyUnknown status
Besancon University Hospital Center
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Besancon CedexFranceCompleted
Institut Bergonie
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BordeauxFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Hôpital Privé des Côtes d'Armor
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PlérinFranceCompleted
Institut De Cancerologie De L Ouest
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St HerblainFranceCompleted
Institut Gustave Roussy
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VillejuifFranceCompleted
High Technology Hospital Medcenter
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BatumiGeorgiaUnknown status
Jsc Evex Hospitals
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KutaisiGeorgiaUnknown status
Multiprofile Clinic Consilium Medulla Llc
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TbilisiGeorgiaUnknown status
INNOVA
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TbilisiGeorgiaUnknown status
Caucasus Medical Centre LLC
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TbilisiGeorgiaUnknown status
Todua Clinic LLC
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TbilisiGeorgiaUnknown status
University General Hospital Attikon
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AthensGreeceCompleted
Alexandra Hospital
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AthensGreeceCompleted
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
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MaroussiGreeceCompleted
Euromedica General Clinic of Thessaloniki
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ThessalonikiGreeceCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyCompleted
European Institute Of Oncology S.r.l.
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MilanItalyCompleted
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyCompleted
Istituto Oncologico Veneto
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PadovaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
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TrevisoItalyCompleted
New Mexico Cancer Care Alliance
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AlbuquerqueUnited StatesUnknown status
Alaska Womens Cancer Care Akwcc
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AnchorageUnited StatesUnknown status
Georgia Cancer Center
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AugustaUnited StatesUnknown status
Texas Oncology-Austin Center
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AustinUnited StatesUnknown status
Billings Clinic Cancer Center
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BillingsUnited StatesUnknown status
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesUnknown status
Minnesota Oncology-Maplewood
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Coon RapidsUnited StatesUnknown status
Barbara Ann Karmanos Cancer Hospital
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DetroitUnited StatesUnknown status
Willamette Valley Cancer Institute
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EugeneUnited StatesUnknown status
Broward Health Medical Center
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Fort LauderdaleUnited StatesUnknown status
Texas Oncology-Fort Worth South Henderson
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Fort WorthUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada
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HendersonUnited StatesUnknown status
The Ohio State University Wexner Medical Center Division of Gynecologic Oncology
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HilliardUnited StatesUnknown status
Midwest Cancer Care
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Kansas CityUnited StatesUnknown status
UCLA Medical Hematology & Oncology
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Los AngelesUnited StatesUnknown status
Miami Cancer Institute
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MiamiUnited StatesUnknown status
Mount Sinai Medical Center Comprehensive Cancer Center
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Miami BeachUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
Laura & Isaac Perlmutter Cancer Ctr
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New YorkUnited StatesUnknown status
Advent Health Medical Group-Orlando 2501
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OrlandoUnited StatesUnknown status
HonorHealth
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PhoenixUnited StatesUnknown status
Virginia Commonwealth University
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RichmondUnited StatesUnknown status
Texas Oncology - San Antonio
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San AntonioUnited StatesUnknown status
Texas Oncology the Woodlands
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ShenandoahUnited StatesUnknown status
Texas Oncology-Tyler
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Sioux FallsUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
Olive View Med Ctr
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SylmarUnited StatesUnknown status
H. Lee Moffitt Cancer Center and Research Institute Hospital
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TampaUnited StatesUnknown status
Arizona Oncology Associates
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TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.