Study Evaluating Lenvatinib, Pembrolizumab, and Pelvic Radiation Therapy for Recurrent or Unresectable Endometrial Cancer with pMMR

What this Trial Is About

This research is focused on patients with recurrent or unresectable endometrial carcinoma that is proficient in mismatch repair pMMR. The study explores the feasibility of combining a fixed dose of pembrolizumab and daily oral lenvatinib with daily abbreviated pelvic external beam radiation therapy EBRT to assess their combined effects on cancer cell growth and spread. It is a Phase 1 clinical trial aiming to determine appropriate dosing and safety. Participants will receive a combination treatment over about 10 to 12 weeks. They will take lenvatinib orally daily starting on Day 1 and continue until the last dose of pelvic radiation. Pembrolizumab will be given intravenously on Days 1, 22, and 43. Whole pelvic hypofractionated EBRT begins on Day 22, followed by a radiation boost using pelvic boost EBRT, vaginal high-dose rate HDR brachytherapy, or both, lasting approximately 7 weeks for the radiation therapy portion. During the study, participants undergo regular monitoring for treatment-related toxicities including dose-limiting toxicities and adverse events up to 12 weeks. Researchers will also evaluate the recommended Phase 2 dose of lenvatinib and overall response rates. Assessments include imaging to measure disease size, performance status evaluations, and laboratory tests to check organ function. Safety and treatment effects are closely observed throughout the treatment period.

Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma