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Clinical Trial Targets Sensitivity of MMR-Deficient Endometrial Tumors to Immune Checkpoint Inhibitors

Some 20-30% of endometrial cancers are caused by a mismatch repair deficiency (dMMR), which disrupts the ability of certain genes to repair DNA replication errors. This characteristic can serve as a prognostic biomarker and inform treatment decisions, because MMR-deficient tumors create neoantigens that can sensitize them to immunotherapy. In particular, immune checkpoint inhibitors such as PD-1 blockades have shown effectiveness against endometrial cancer.

A randomized phase 2 clinical trial underway at Roswell Park Comprehensive Cancer Center and 17 other centers nationwide will evaluate a combination of two immune checkpoint inhibitors in patients with advanced or recurrent disease, whose prognosis is poor and whose options are limited. Emese Zsiros, MD, PhD, FACOG, Chair, Department of Gynecologic Oncology, and Co-Leader of the Tumor Immunology and Immunotherapy CCSG Program at Roswell Park, serves as site principal investigator for the study, Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma (NCT05112601).

The clinical trial will compare the efficacy of nivolumab (Opdivo), a PD-1-binding immune checkpoint inhibitor, plus ipilimumab (Yervoy), an anti-CTLA-4 inhibitor, versus nivolumab alone. Monoclonal antibodies such as nivolumab and ipilimumab stimulate the immune system to attack cancer cells and interfere with the cells’ ability to grow and spread. While previous clinical trials have shown evidence that this combination can shrink or stabilize other types of dMMR tumors, until now it has not been evaluated in endometrial cancer.

“This trial welcomes patients previously treated with immune checkpoint inhibitors, marking a crucial advancement in utilizing combination immunotherapy to bring renewed hope to those with MMR-deficient recurrent endometrial cancer,” says Dr. Zsiros.

Sponsored by the National Cancer Institute, the study expects to enroll 90 patients.

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