Navtemadlin as Maintenance Treatment for Women with TP53 Wild-Type Advanced or Recurrent Endometrial Cancer After Chemotherapy Response

What this Trial Is About

Researchers are evaluating navtemadlin as a maintenance treatment for women with advanced or recurrent endometrial cancer who have responded to chemotherapy. The study focuses on patients with tumors that have a specific gene status called TP53 wild type. It aims to determine the best dose of navtemadlin and then compare its effectiveness and safety to a placebo in preventing cancer progression. The trial has two parts Part 1 tests two different doses of navtemadlin, given orally once daily for seven days in a 28-day cycle, alongside an observational control group that receives no treatment. Part 2 compares the selected navtemadlin dose to placebo, also given orally on the same schedule. The study uses random assignment and is designed to keep participants and researchers unaware of the treatment allocation. Participants will be monitored for safety and how well the treatment works through regular assessments over several months. The main outcomes include determining the appropriate navtemadlin dose and measuring progression-free survival. Additional evaluations include the time until the next treatment, disease control rate, and drug levels in the body. The study period may last up to 50 months, with ongoing safety monitoring throughout.

Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer