Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.

Official Title

A Phase III Randomized Trial of Radiation +/- Pembrolizumab (MK-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

Details

Keywords

Endometrial Endometrioid Adenocarcinoma, Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, Stage II Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, Carcinoma, Endometrial Neoplasms, Endometrioid Carcinoma, Carcinosarcoma, Mullerian Mixed Tumor, Pembrolizumab, Biospecimen Collection, Brachytherapy, Computed Tomography, External Beam Radiation Therapy, Magnetic Resonance Imaging, Quality-of-Life Assessment, X-Ray Imaging, EBRT, brachytherapy, EBRT, brachytherapy, pembrolizumab

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT04214067
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 168 study participants
Last Updated