RecruitingPhase 2NCT04774419

Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery

Adjuvant Checkpoint Blockade Plus Radiation In Locally Advanced, Mismatch Repair Deficient/Microsatellite Instability-High (MMR-D/MSI-H) Endometrial Cancer

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

62 participants

Start Date

Apr 2, 2021

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer

Summary

This study will test whether the combination of radiation and Dostarlimab is an effective treatment for women with MMR-D/MSI-H endometrial cancer who have recently undergone surgery.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests adding an immunotherapy drug called dostarlimab (TSR-042) to radiation therapy for people with advanced endometrial cancer (cancer of the uterine lining) after surgery. The study focuses on tumors with specific genetic features that may respond better to immunotherapy. **You may be eligible if...** - You are 18 or older with stage III or IVA endometrial cancer - You have had complete surgical staging (full removal of the uterus and nearby lymph nodes) - Your tumor has a specific genetic feature: mismatch repair deficiency (MMR-D), microsatellite instability (MSI-H), or a POLE mutation - You are in good physical condition (ECOG 0–1) - There is no visible remaining cancer after surgery **You may NOT be eligible if...** - Your surgery was not complete or you have measurable disease left after surgery - Your tumor does not have the required genetic features - You have had prior immunotherapy or radiation to the relevant area - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONIntensity modulated radiation therapy (IMRT)

To the pelvic nodes and vaginal cuff (total dose of 45-50.4Gy at 1.8 Gy per fraction) for 5-6 weeks.

DRUGDostarlimab

IV Dostarlimab every 3 weeks for 4 cycles followed by 1 dose of 1000mg (C5). Patients will receive a maximum of 5 cycles of Dostarlimab.

RADIATIONHypofractionated IMRT

Treatment will consist of short-course, hypofractionated IMRT to deliver 25 Gy to the vaginal cuff and pelvic lymph nodes in 5 daily fractions over one week.