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

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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).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have had surgery for stage III/IVA MMR-D/MSI-H endometrial cancer at least 3 weeks but no more than 12 weeks before receiving the study treatment.
  • Prior chemotherapy or immunotherapy for endometrial cancer is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ying Liu at 646-888-4946.

Protocol

20-491

Phase

II

Disease Status

Newly Diagnosed

Investigator