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.
NCT ID: NCT04463771
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
206 participants
INTERVENTIONAL
2021-01-26
2026-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group D - retifanlimab + pemigatinib
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)
retifanlimab
INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
pemigatinib
pemigatinib will be administered orally QD.
Group E - retifanlimab + epacadostat
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat
retifanlimab
INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
epacadostat
epacadostat will be administered orally BID.
Group F - retifanlimab + INCAGN02385 and INCAGN02390
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously
INCAGN02385
INCAGN2385 will be administered every 2 weeks
INCAGN02390
INCAGN2390 will be administered every 2 weeks
Group C - retifanlimab + epacadostat
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)
retifanlimab
INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
epacadostat
epacadostat will be administered orally BID.
Group A - retifanlimab
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
retifanlimab
INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
Group B - retifanlimab
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
retifanlimab
INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
Interventions
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retifanlimab
INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
epacadostat
epacadostat will be administered orally BID.
pemigatinib
pemigatinib will be administered orally QD.
INCAGN02385
INCAGN2385 will be administered every 2 weeks
INCAGN02390
INCAGN2390 will be administered every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Histologically confirmed diagnosis of sarcoma of the uterus.
* Has disease eligible for potentially curative 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):
* Known active CNS metastases and/or carcinomatous meningitis.
* Has known active hepatitis B or C.
* Has received a live vaccine within 28 days of the planned start of study treatment.
* Evidence of interstitial lung disease or active, noninfectious pneumonitis.
* Participants who are known to be HIV-positive with some protocol exceptions.
18 Years
FEMALE
No
Sponsors
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GOG Foundation
NETWORK
European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Cornfield
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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European Institute of Oncology
Milan, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
Napoli, , Italy
Iov - Istituto Oncologico Veneto Irccs
Padua, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Roma, , Italy
Ospedale Santa Maria Ca Foncello
Treviso, , Italy
Alaska Womens Cancer Care Akwcc
Anchorage, Alaska, United States
Honorhealth
Phoenix, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
UCLA Medical Hematology & Oncology
Los Angeles, California, United States
Olive View Med Ctr
Sylmar, California, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, United States
Advent Health Medical Group-Orlando 2501
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, United States
Georgia Cancer Center
Augusta, Georgia, United States
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, United States
Minnesota Oncology-Maplewood
Coon Rapids, Minnesota, United States
Midwest Cancer Care
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Laura & Isaac Perlmutter Cancer Ctr
New York, New York, United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
The Ohio State University Wexner Medical Center Division of Gynecologic Oncology
Hilliard, Ohio, United States
Willamette Valley Cancer Institute
Eugene, Oregon, United States
Texas Oncology-Tyler
Sioux Falls, South Dakota, United States
Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology-Austin Center
Austin, Texas, United States
Texas Oncology-Fort Worth South Henderson
Fort Worth, Texas, United States
Texas Oncology San Antonio
San Antonio, Texas, United States
Texas Oncology the Woodlands
Shenandoah, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
O.L.V Ziekenhuis
Aalst, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Ghent University Hospital
Ghent, , Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, , Belgium
Chu Ucl Namur de Saint Elisabeth
Namur, , Belgium
Chu Besancon Hospital Jean Minjoz
Besançon, , France
Institut Bergonie
Bordeaux, , France
Hospital Cochin Cancerologie
Paris, , France
Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie
Plérin, , France
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
Saint-Herblain, , France
Institut Gustave Roussy
Villejuif, , France
High Technology Hospital Medcenter
Batumi, , Georgia
Jsc Evex Hospitals
Kutaisi, , Georgia
Todua Clinic, Llc
Tbilisi, , Georgia
Caucasus Medical Centre Llc
Tbilisi, , Georgia
INNOVA
Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla Llc
Tbilisi, , Georgia
Charite - Campus Virchow-Klinikum
Berlin, , Germany
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, , Germany
Klinikum Kassel Gmbh
Kassel, , Germany
Universitarsfrauenklinik Ulm
Ulm, , Germany
Alexandra General Hospital of Athens
Athens, , Greece
University Hospital of West Attica - Attikon
Athens, , Greece
Hygeia Hospital
Marousi, , Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, , Greece
Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
Bologna, , Italy
Presidio Ospedaliero Di Summa Antonio Perrino
Brindisi, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola, , Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milan, , Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milan, , Italy
Countries
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Related Links
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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.
Other Identifiers
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2022-502600-79-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-000496-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCMGA 0012-204
Identifier Type: -
Identifier Source: org_study_id
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