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.

• Status: Recruiting
• Trial end date: 2023-11-08
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Collaborators: European Network for Gynaecological Oncological Trial groups(ENGOT); GOG Foundation; Gynecologic Oncology Group

Criteria

Inclusion Criteria:

• 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).

• ECOG performance status 0 to 1.

• Willingness to avoid pregnancy.

Exclusion Criteria:

• 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 ≤ Grade 1 or baseline unless approved by the medical monitor.

• 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.