An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)
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.
To evaluate antitumor activity of INCMGA00012 in Group A.
To further evaluate clinical efficacy of INCMGA00012 monotherapy and evaluate clinical activity in the combinations.
To evaluate the safety and tolerability of INCMGA00012 as monotherapy and in combination.
Ability to comprehend and willingness to sign a written ICF for the study. 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 and B: 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.
Must have at least 1 measurable tumor lesion per RECIST v1.1.
Willing to provide tumor tissue sample (fresh or archived).
Group A 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 > Groups C and D (combinations): limiting immune-related toxicity during prior checkpoint inhibitor 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.
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