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.

NCT04463771 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: INCMGA 0012-2042022-502600-79-002020-000496-20
• Study Type: interventional
• Target: 206
• Locations: 7 countries
• Sites: 65

Brief 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.

Conditions

Endometrial Cancer

Keywords

Endometrial Carcinoma; Endometrium Cancer; Neoplasms Endometrial; Advanced; Metastatic; PD-1; PD-L1; retifanlimab; INCMGA0012; INCAGN02385; INCAGN02390; PODIUM; LAG-3; TIM-3

Outcome Measures

Primary Outcomes (1)

• Group A - Objective Response Rate

  Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee

  up to 2.5 years

Secondary Outcomes (11)

• Group A -Duration of Response

  up to 2.5 years

• Group A - Disease Control Rate

  up to 2.5 years

• Group A - Overall Survival

  up to 3.5 years

• Group A - Progression Free Survival

  up to 3.5 years

• Group B -Duration of Response

  up to 2.5 years

Study Arms (6)

Group A - retifanlimab

EXPERIMENTAL

Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously

Drug: retifanlimab

Group B - retifanlimab

EXPERIMENTAL

Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously

Drug: retifanlimab

Group C - retifanlimab + epacadostat

EXPERIMENTAL

Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)

Drug: retifanlimab; Drug: epacadostat

Group D - retifanlimab + pemigatinib

EXPERIMENTAL

Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)

Drug: retifanlimab; Drug: pemigatinib

Group E - retifanlimab + epacadostat

EXPERIMENTAL

Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat

Drug: retifanlimab; Drug: epacadostat

Group F - retifanlimab + INCAGN02385 and INCAGN02390

EXPERIMENTAL

Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously

Drug: INCAGN02385; Drug: INCAGN02390

Interventions

retifanlimab DRUG

INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.

Also known as: INCMGA00012

Group A - retifanlimab; Group B - retifanlimab; Group C - retifanlimab + epacadostat; Group D - retifanlimab + pemigatinib; Group E - retifanlimab + epacadostat

epacadostat DRUG

epacadostat will be administered orally BID.

Group C - retifanlimab + epacadostat; Group E - retifanlimab + epacadostat

pemigatinib DRUG

pemigatinib will be administered orally QD.

Group D - retifanlimab + pemigatinib

INCAGN02385 DRUG

INCAGN2385 will be administered every 2 weeks

Group F - retifanlimab + INCAGN02385 and INCAGN02390

INCAGN02390 DRUG

INCAGN2390 will be administered every 2 weeks

Group F - retifanlimab + INCAGN02385 and INCAGN02390

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Incyte Corporation: lead
• GOG Foundation: collaborator
• European Network of Gynaecological Oncological Trial Groups (ENGOT): collaborator

Study Sites (65)

Alaska Womens Cancer Care Akwcc

Anchorage, Alaska, 99508, United States

Location

Honorhealth

Phoenix, Arizona, 85016, United States

Location

Arizona Oncology Associates

Tucson, Arizona, 85711, United States

Location

UCLA Medical Hematology & Oncology

Los Angeles, California, 90048, United States

Location

Olive View Med Ctr

Sylmar, California, 91342, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Mount Sinai Medical Center Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Advent Health Medical Group-Orlando 2501

Orlando, Florida, 32804, United States

Location

H. Lee Moffitt Cancer Center and Research Institute Hospital

Tampa, Florida, 33612-9497, United States

Location

Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

Barbara Ann Karmanos Cancer Hospital

Detroit, Michigan, 48201, United States

Location

Minnesota Oncology-Maplewood

Coon Rapids, Minnesota, 55433, United States

Location

Midwest Cancer Care

Kansas City, Missouri, 64132, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89074, United States

Location

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87131, United States

Location

Laura & Isaac Perlmutter Cancer Ctr

New York, New York, 10016, United States

Location

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

Hilliard, Ohio, 43026, United States

Location

Willamette Valley Cancer Institute

Eugene, Oregon, 97401-8122, United States

Location

Texas Oncology-Tyler

Sioux Falls, South Dakota, 57104, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Texas Oncology-Austin Center

Austin, Texas, 78731, United States

Location

Texas Oncology-Fort Worth South Henderson

Fort Worth, Texas, 76104-3902, United States

Location

Texas Oncology San Antonio

San Antonio, Texas, 78240, United States

Location

Texas Oncology the Woodlands

Shenandoah, Texas, 77380, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

O.L.V Ziekenhuis

Aalst, 09300, Belgium

Location

Institut Jules Bordet

Brussels, 01000, Belgium

Location

Ghent University Hospital

Ghent, 09000, Belgium

Location

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, 03000, Belgium

Location

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 04000, Belgium

Location

Chu Ucl Namur de Saint Elisabeth

Namur, 05000, Belgium

Location

Chu Besancon Hospital Jean Minjoz

Besançon, 25000, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Hospital Cochin Cancerologie

Paris, 75006, France

Location

Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie

Plérin, 22190, France

Location

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

Saint-Herblain, 44800, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

High Technology Hospital Medcenter

Batumi, 06000, Georgia

Location

Jsc Evex Hospitals

Kutaisi, 04600, Georgia

Location

Todua Clinic, Llc

Tbilisi, 00112, Georgia

Location

Caucasus Medical Centre Llc

Tbilisi, 00186, Georgia

Location

INNOVA

Tbilisi, 00186, Georgia

Location

Multiprofile Clinic Consilium Medulla Llc

Tbilisi, 00186, Georgia

Location

Charite - Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

University Clinic Carl Gustav Carus Technical University Dresden

Dresden, 01307, Germany

Location

Klinikum Kassel Gmbh

Kassel, 34125, Germany

Location

Universitarsfrauenklinik Ulm

Ulm, 89075, Germany

Location

Alexandra General Hospital of Athens

Athens, 11528, Greece

Location

University Hospital of West Attica - Attikon

Athens, 12462, Greece

Location

Hygeia Hospital

Marousi, 15123, Greece

Location

Euromedica General Clinic of Thessaloniki

Thessaloniki, 54645, Greece

Location

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

Bologna, 40138, Italy

Location

Presidio Ospedaliero Di Summa Antonio Perrino

Brindisi, 72100, Italy

Location

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

Meldola, 47014, Italy

Location

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

Milan, 20132, Italy

Location

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

Milan, 20133, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, 80131, Italy

Location

Iov - Istituto Oncologico Veneto Irccs

Padova, 35128, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Roma, 00168, Italy

Location

Ospedale Santa Maria Ca Foncello

Treviso, 31100, Italy

Location

Related Links

• 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.

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplasm Metastasis

Interventions

epacadostat; pemigatinib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Cornfield

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: January 26, 2021
• Primary Completion: May 29, 2026
• Study Completion: May 29, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

IT (10); US (29); BE (6); GR (4); FR (6); GE (6); DE (4)