Phase 2b Study of Dostarlimab Immunotherapy for Early-Stage Mismatch Repair Deficient Endometrioid Endometrial Cancer in Women

What this Trial Is About

Researchers are evaluating dostarlimab, an immunotherapy drug, as a potential alternative to surgery for women with early-stage endometrial cancer that has Mismatch Repair deficiency, a genetic cause found in 20-30% of cases. This Phase 2b study aims to determine the effectiveness and safety of dostarlimab in treating this specific type of cancer, especially for women who cannot or prefer not to have surgery, including those wishing to preserve fertility or those with other health concerns. Participants will receive seven sessions of dostarlimab over 12 months. The treatment schedule includes four cycles every three weeks, followed by a three-week break, then three cycles every six weeks. This single-arm, open-label study will test this regimens ability to eliminate endometrial cancer without surgery, exploring a less invasive treatment option. During the study, participants will undergo clinical evaluations, imaging scans, laboratory tests, and monitoring for immune-related adverse events. Researchers will assess cancer absence at six months, safety and tolerability throughout treatment and follow-up at 9 and 12 months, and longer-term changes in clinical and laboratory parameters. The study also includes participant feedback and explores fertility outcomes. Total participation lasts about one year.

SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)