Status:
ACTIVE_NOT_RECRUITING
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.
Lead Sponsor:
Incyte Corporation
Collaborating Sponsors:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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-bas...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2026
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04463771
Start Date
January 26 2021
End Date
July 10 2026
Last Update
December 10 2025
Active Locations (65)
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1
Alaska Womens Cancer Care Akwcc
Anchorage, Alaska, United States, 99508
2
Honorhealth
Phoenix, Arizona, United States, 85016
3
Arizona Oncology Associates
Tucson, Arizona, United States, 85711
4
UCLA Medical Hematology & Oncology
Los Angeles, California, United States, 90048