Testing Pembrolizumab with Radiation for Early Stage Endometrial Cancer

Program Overview

This phase III trial is investigating if combining the immunotherapy drug pembrolizumab with radiation therapy is more effective than radiation alone in preventing the return of stage I-II endometrial cancer. Pembrolizumab may help the immune system attack cancer cells, while radiation uses high-energy x-rays to kill cancer cells and shrink tumors. The study aims to see if this combination can reduce the risk of cancer recurrence more effectively than radiation alone.

Description

The main goal of this study is to compare the effectiveness of radiation therapy alone versus radiation combined with pembrolizumab in preventing cancer from coming back over three years in women with high intermediate risk stage I/II endometrial cancer.

Secondary goals include evaluating the safety of the combined treatment, understanding patterns of cancer recurrence, and measuring survival rates over five years. The study will also assess the impact of the treatment on quality of life and side effects.

Participants are divided into two groups:

• Group 1: Receives radiation therapy to the pelvic area for 5-6 weeks, followed by a specific type of internal radiation called vaginal brachytherapy.
• Group 2: Receives the same radiation treatment as Group 1, plus pembrolizumab given through an IV every six weeks for up to a year.

Both groups will have regular blood tests and imaging scans like CT or MRI to monitor their health and the cancer's response to treatment. After completing the treatment, participants will have follow-up visits every three months for two years, then every six months for three more years.

Eligibility Criteria

Locations