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.

Completed · Phase 2

Conditions studied: Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT04463771

Run by

Incyte Corporation

People needed

206

Starts

2021-01-26

Expected to finish

2026-05-29

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Alaska Womens Cancer Care Akwcc — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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