Study on the Safety and Effectiveness of Retifanlimab Alone or with Other Treatments for Advanced Endometrial Cancer After Platinum-based Chemotherapy

Inclusion Criteria

• Women aged 18 or older who can understand and sign a consent form.
• Diagnosed with advanced or metastatic endometrial cancer that has worsened after at least one round of platinum-based chemotherapy.
• For Groups A, B, and E: Must not have been treated with a PD-(L)1 inhibitor before.
• Group A: Tumor must be MSI-High.
• Group B: Tumor must have deficient MMR or be an ultra-mutated POLE tumor.
• Group D: Tumor must have an FGFR 1,2,3 mutation or alteration.
• Group E: Tumor must be MSS and PD-L1 positive.
• Group F: Must show disease progression after PD-(L)1 therapy and have an MSI-H tumor.
• Must have at least one measurable tumor.
• Willing to provide a tumor tissue sample.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must agree to avoid pregnancy during the study.

Exclusion Criteria

• For Groups A, B, and E: Cannot have carcinosarcoma of the uterus.
• Cannot have sarcoma of the uterus.
• Cannot have disease that can be potentially cured with other treatments.
• Cannot have received cancer treatment within 28 days before starting the study treatment, except for localized radiotherapy.
• Must not have unresolved side effects from previous treatments unless approved by the medical monitor.
• For Groups C, D, and F: Cannot have had severe immune-related side effects from previous checkpoint inhibitor therapy.
• Group F: Cannot have been treated with LAG-3, TIM-3 therapy, or lenvatinib, or have multiple metastases with mixed responses to previous anti-PD-(L)1 therapy.
• Cannot have an active autoimmune disease requiring high-dose steroids or immunosuppressive drugs within 14 days before starting the study.
• Cannot be on chronic high-dose steroids.
• Cannot have active brain metastases or carcinomatous meningitis.
• Cannot have active hepatitis B or C.
• Cannot have received a live vaccine within 28 days before starting the study.
• Cannot have interstitial lung disease or active, noninfectious pneumonitis.
• Cannot be HIV-positive, with some exceptions.