A Randomized Phase II Trial of Immunotherapy with Dual Immune Checkpoint Inhibitors Compared to Anti-PD1 Monotherapy in Patients with Deficient Mismatch Repair System Recurrent Endometrial Carcinoma (NRG-GY025)

May 11 2022

NRG-GY025 is a randomized phase II trial that is currently active and enrolling.

This trial is examining the efficacy of dual immune checkpoint inhibition (with nivolumab and low dose ipilimumab) compared to nivolumab monotherapy in patients with recurrent endometrial cancer with a deficient mismatch repair system (dMMR).

NRG-GY025 study will enroll patients with recurrent endometrial cancer with evidence of a deficient mismatch repair system (also known as microsatellite instability- high, MSI-H). Eligible patients will be randomly assigned (2:1) to receive either: A- dual immunotherapy with nivolumab (anti-PD1) combined with low dose ipilimumab (anti-CTLA4) or B- single agent nivolumab (anti-PD1). The primary goal of the study is to compare the efficacy of dual vs. single agent immunotherapy in these patients with highly immunogenic tumors.

“NRG-GY025 will help determine if dual immunotherapy targeting PD1 and CTLA4 immune checkpoints is more effective and prolongs progression-free survival compared to single agent immunotherapy targeting the PD1 immune checkpoint alone in patients with recurrent endometrial cancer with dMMR (also called MSI-H). We know that these are immunogenic tumors and prior studies have shown that anti-PD1 therapy is active with good outcomes in the recurrent setting.Yet approximately 50-60% of these patients do not respond to single agent therapy. Therefore, this study will help us understand if dual therapy will be beneficial not only in increasing the percentage of the patients who benefit from immunotherapy but also the duration of progression-free survival and response to therapy. Nivolumab combined with low dose ipilimumab has a well-established safety profile based on many studies and is FDA approved in several other indications” stated Haider Mahdi, MD, MPH, of the University of Pittsburgh School of Medicine, the Principal Investigator of the NRG-GY025 trial.

For more information about the NRG-GY025 study, click here:NCT05112601

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