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.

Last updated: May 30, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Not Recruiting

Phase

2

Condition

Endometriosis

Endometrial Cancer

Vaginal Cancer

Treatment

epacadostat

INCAGN02390

pemigatinib

Clinical Study ID

NCT04463771
INCMGA 0012-204
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to comprehend and willingness to sign a written ICF for the study. Note forGermany: This excludes individuals who are housed in an institution due to officialor court order Women 18 years of age or older (or as applicable per local countryrequirements).

  • Histologically confirmed diagnosis of advanced or metastatic endometrial cancer withdisease progression on or after treatment with at least 1 platinum-containingregimen 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 alterationcharacterized 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)1therapy 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

Exclusion Criteria:

  • Group A, B and E only: Histologically confirmed diagnosis of carcinosarcoma of theuterus.

  • 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 studytreatment, with the exception of localized radiotherapy.

  • Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline unlessapproved by the medical monitor.

  • Groups C, D and F (combinations): limiting immune-related toxicity during priorcheckpoint inhibitor therapy.

  • Group F only: Previous treatment with LAG-# or TIM-3 therapy or lenvatinib; multiplemetastases that achieved mixed tumor response to prior anti-PD-(L)1 therapy

  • Has an active autoimmune disease requiring systemic immunosuppression withcorticosteroids (> 10 mg/day of prednisone or equivalent) or immunosuppressive drugswithin 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.

Study Design

Total Participants: 206
Treatment Group(s): 5
Primary Treatment: epacadostat
Phase: 2
Study Start date:
January 26, 2021
Estimated Completion Date:
July 10, 2026

Connect with a study center

  • O.L.V Ziekenhuis

    Aalst, 09300
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Brussels, 01000
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Bruxelles, 01000
    Belgium

    Site Not Available

  • Ghent University Hospital

    Gent, 09000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    LI�GE, 04000
    Belgium

    Site Not Available

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liege, 04000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liã¨ge, 04000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 04000
    Belgium

    Site Not Available

  • Chu Ucl Namur de Saint Elisabeth

    Namur, 05000
    Belgium

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, 100044
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, 410000
    China

    Site Not Available

  • West China Second University Hospital, Sichuan University

    Chengdu, 610066
    China

    Site Not Available

  • Chongqing University Cancer Hospital

    Chongqing, 400030
    China

    Site Not Available

  • Sun Yat-Sen Memorial Hospital Sun Yat-Sen University

    Guangzhou, 510000
    China

    Site Not Available

  • University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)

    Hefei, 230001
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, 250000
    China

    Site Not Available

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, 210008
    China

    Site Not Available

  • Tsingdao Central Hospital

    Qingdao, 266042
    China

    Site Not Available

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, 200011
    China

    Site Not Available

  • The Second Hospital of Shanxi Medical University

    Taiyuan, 30001
    China

    Site Not Available

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003
    China

    Site Not Available

  • Henan Cancer Hostipal

    Zhengzhou, 450008
    China

    Site Not Available

  • Chu Besancon Hospital Jean Minjoz

    Besancon, 25000
    France

    Site Not Available

  • Institut Bergonie

    Bordeaux Cedex, 33076
    France

    Site Not Available

  • Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie

    PL�RIN, 22198
    France

    Site Not Available

  • Hospital Cochin Cancerologie

    Paris, 75006
    France

    Site Not Available

  • Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie

    Plerin, 22198
    France

    Site Not Available

  • Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie

    Plã©rin, 22190
    France

    Site Not Available

  • Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie

    Plérin, 22190
    France

    Site Not Available

  • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

    Saint Herblain, 44800
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif Cedex, 94805
    France

    Site Not Available

  • High Technology Hospital Medcenter

    Batumi, 06000
    Georgia

    Site Not Available

  • Jsc Evex Hospitals

    Kutaisi, 04600
    Georgia

    Site Not Available

  • Caucasus Medical Centre Llc

    Tbilisi, 00186
    Georgia

    Site Not Available

  • INNOVA

    Tbilisi, 00186
    Georgia

    Site Not Available

  • Ltd Innova

    Tbilisi, 00186
    Georgia

    Active - Recruiting

  • Multiprofile Clinic Consilium Medulla Llc

    Tbilisi, 00186
    Georgia

    Site Not Available

  • Todua Clinic, Llc

    Tbilisi, 00112
    Georgia

    Site Not Available

  • Charite - Campus Virchow-Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Universitatsklinikum Bonn Aoer

    Bonn, 53127
    Germany

    Site Not Available

  • University Clinic Carl Gustav Carus Technical University Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Klinikum Kassel Gmbh

    Kassel, 34125
    Germany

    Site Not Available

  • Universitarsfrauenklinik Ulm

    ULM, 89075
    Germany

    Site Not Available

  • Alexandra General Hospital of Athens

    Athens, 11528
    Greece

    Site Not Available

  • University Hospital of West Attica - Attikon

    Athens, 12462
    Greece

    Site Not Available

  • Hygeia Hospital

    Marousi, 15123
    Greece

    Site Not Available

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 54645
    Greece

    Site Not Available

  • Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI

    Bologna, 40138
    Italy

    Active - Recruiting

  • L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi

    Bologna, 40138
    Italy

    Active - Recruiting

  • Presidio Ospedaliero Di Summa Antonio Perrino

    Brindisi, 72100
    Italy

    Site Not Available

  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

    Meldola, 47014
    Italy

    Site Not Available

  • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

    Milano, 20133
    Italy

    Site Not Available

  • European Institute of Oncology

    Milano, 20141
    Italy

    Site Not Available

  • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Irccs Fondazione Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Iov - Istituto Oncologico Veneto Irccs

    Padova, 35128
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Roma, 00168
    Italy

    Site Not Available

  • Ospedale Santa Maria Ca Foncello

    Treviso, 31100
    Italy

    Site Not Available

  • Alaska Womens Cancer Care Akwcc

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Honorhealth

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Arizona Oncology Associates

    Tucson, Arizona 85711
    United States

    Site Not Available

  • UCLA Medical Hematology & Oncology

    Los Angeles, California 90048
    United States

    Site Not Available

  • Olive View Med Ctr

    Sylmar, California 91342
    United States

    Site Not Available

  • Broward Health Medical Center

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Miami Cancer Institute

    Miami, Florida 33176
    United States

    Site Not Available

  • Mount Sinai Medical Center Comprehensive Cancer Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Advent Health Medical Group-Orlando 2501

    Orlando, Florida 32804
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute Hospital

    Tampa, Florida 33612-9497
    United States

    Site Not Available

  • Georgia Cancer Center

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Hospital

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Minnesota Oncology-Maplewood

    Coon Rapids, Minnesota 55433
    United States

    Site Not Available

  • Minnesota Oncology - Maplewood

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Minnesota Oncology-Maplewood

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Midwest Cancer Care

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Billings Clinic Cancer Center

    Billings, Montana 59101
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada 89074
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Columbia University Hervert Irving Comprehensive Cancer Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Laura & Isaac Perlmutter Cancer Ctr

    New York, New York 10016
    United States

    Site Not Available

  • Nyu Clinical Cancer Center

    New York, New York 10032
    United States

    Active - Recruiting

  • University of North Carolina At Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

    Hilliard, Ohio 43026
    United States

    Site Not Available

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma 73104-5418
    United States

    Site Not Available

  • Willamette Valley Cancer Institute

    Eugene, Oregon 97401-8122
    United States

    Site Not Available

  • Texas Oncology - Tyler

    Sioux Falls, South Dakota 57104
    United States

    Active - Recruiting

  • Texas Oncology-Tyler

    Sioux Falls, South Dakota 57104
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Oncology-Austin Center

    Austin, Texas 78731
    United States

    Site Not Available

  • Texas Oncology

    Fort Worth, Texas 76104-3902
    United States

    Active - Recruiting

  • Texas Oncology-Fort Worth South Henderson

    Fort Worth, Texas 76104-3902
    United States

    Site Not Available

  • Memorial Hermann Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Oncology San Antonio

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Texas Oncology the Woodlands

    Shenandoah, Texas 77380
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

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