Phase II Study Comparing Nivolumab Alone to Nivolumab Plus Ipilimumab for Women With Recurrent Endometrial Cancer Having Deficient Mismatch Repair

What this Trial Is About

Researchers are evaluating whether the combination of nivolumab and ipilimumab is more effective than nivolumab alone in shrinking tumors in patients with recurrent endometrial carcinoma that has a deficient mismatch repair system dMMR. This phase II trial focuses on patients whose cancer has returned after being undetectable and investigates the potential benefits of dual immune checkpoint blockade compared to monotherapy. The study aims to improve progression-free survival and assess overall response and safety in this specific patient population. Participants are randomly assigned to one of two treatment groups. One group receives nivolumab intravenously every three weeks along with ipilimumab every six weeks for up to 8 cycles, followed by nivolumab alone every four weeks. The other group receives nivolumab alone every three weeks for up to 8 cycles, then every four weeks thereafter. Patients who achieve a complete response continue nivolumab for an additional 12 months. Optional tissue and blood sample collections, along with regular CT or MRI scans, occur throughout the trial. During the study, patients are closely monitored with imaging scans and sample collections to evaluate tumor response and progression. They have follow-up visits every three months for two years, then every six months for an additional three years. Researchers measure progression-free survival up to five years after enrollment, along with overall survival, tumor response rates, and adverse events. Safety assessments and detailed evaluations are conducted to understand the effects of the treatments over time.

Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma