A Phase III Study of Radiation Therapy with or without Pembrolizumab Immunotherapy to Treat Newly Diagnosed Early-Stage High- to Intermediate-Risk Endometrial Cancer

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Full Title

A Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer (NRG-GY020) (CIRB)

Purpose

Endometrial cancers that are what is called “DNA mismatch repair deficient” tend to be more sensitive to immunotherapies, which boost the power of the immune system to find and kill cancer cells. However, immunotherapy is currently only approved for endometrial cancer if the cancer has come back after receiving chemotherapy.

In this study, researchers want to see if adding pembrolizumab immunotherapy to radiation therapy (internal or external) is more effective than radiation therapy alone in women newly diagnosed with DNA mismatch repair-deficient endometrial cancer that has an intermediate or high risk of coming back after treatment. Patients will be randomly assigned to receive radiation therapy alone or with pembrolizumab.

Pembrolizumab works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. Pembrolizumab 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 newly diagnosed stage I or II DNA mismatch repair-deficient endometrioid endometrial cancer that has an intermediate or high risk of coming back after treatment.
  • Patients may not have received prior therapy for endometrial cancer, including hormonal therapy, chemotherapy, targeted therapy, immunotherapy or radiation therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Dmitriy Zamarin at 646-888-4882.

Protocol

20-125

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators