A Phase II Study of Radiation Therapy and TSR-042 Immunotherapy After Surgery in Women with Endometrial Cancer

Full Title

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

Purpose

Cells that are “mismatch repair-deficient” (MMR-D) or “microsatellite instability-high” (MSI-H) are unable to repair mistakes made during cell growth. Women with MMR-D/MSI-H endometrial cancer tend not to respond well to the chemotherapy they receive after surgery. Researchers are exploring the use of the immunotherapy TSR-042 (also called dostarlimab) as an alternative to chemotherapy. Radiation therapy is also used after surgery for endometrial cancer.

Adding TSR-042 to radiation therapy may help women with MMR-D/MSI-H endometrial cancer because the combination of radiation and immunotherapy can boost the immune response. TSR-042 takes the brakes off the immune response, enabling the immune system to detect and destroy cancer cells. The purpose of this study is to assess safety and effectiveness of the combination of radiation therapy and TSR-042 in women with MMR-D/MSI-H endometrial cancer who have recently undergone surgery. TSR-042 is given intravenously (by vein).

Protocol
20-491
Phase
Phase II (phase 2)
Disease Status
Newly Diagnosed
Investigator
ClinicalTrials.gov ID
NCT04774419