Phase 2 Study of First-line Carboplatin and Paclitaxel with Pembrolizumab Followed by Maintenance Pembrolizumab With or Without Nesuparib in Women with Advanced or Recurrent MMR-proficient Endometrial Cancer

What this Trial Is About

Researchers are evaluating a combination of pembrolizumab and nesuparib as a maintenance therapy for female patients with MMR-proficient advanced and recurrent endometrial cancer. The study includes a safety run-in phase to assess whether the treatment is tolerable and a randomized phase to compare the effectiveness of pembrolizumab alone versus pembrolizumab with nesuparib. The main goal is to understand how these treatments affect progression-free survival. Participants receive first-line chemotherapy with pembrolizumab, paclitaxel, and carboplatin for six cycles, followed by maintenance treatment. During maintenance, one group receives pembrolizumab alone, while another receives pembrolizumab combined with nesuparib taken orally daily. Pembrolizumab is given intravenously every six weeks, and the treatment period includes up to 14 maintenance cycles. The study has two parts an initial safety phase and a randomized phase comparing the two maintenance treatments. Throughout the study, participants will have regular assessments including monitoring for dose-limiting toxicities, tumor response evaluations, and survival outcomes. Blood tests and tumor tissue samples are collected to check organ function and molecular markers. Safety and treatment effects will be followed up for up to 18 months after enrollment. The total number of pembrolizumab cycles, including chemotherapy and maintenance, can be up to 20. Participants will be closely monitored for side effects and disease progression during the trial.

First-line Carboplatin and Paclitaxel in Combination With Pembrolizumab, Followed by Maintenance Pembrolizumab With or Without Nesuparib, in Patients With Newly Diagnosed Advanced or Recurrent MMR-proficient (pMMR) Endometrial Cancer