NRG-GY020

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Protocol Information

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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

Principal Investigator

Floor Backes, MD

Status

Complete

Open to Accrual

February 7, 2020

Temporarily Closed to Accrual

February 7, 2020

Open to Accrual

February 18, 2020

Closed to Accrual

August 29, 2022

Closed to Accrual & Treatment

September 5, 2023

Complete

December 30, 2025


Disease Site

Gynecologic [GY] Uterine Corpus

Phase

III

Developmental Therapeutics

No

Primary Objective

To compare the 3-year recurrence-free survival of women with high intermediate risk (HIR) Stage I/II mismatch repair deficient (dMMR) endometrioid endometrial cancer treated with radiation and MK-3475 (pembrolizumab) versus radiation alone.

Patient Population

Women with Stage I or II endometrioid endometrial cancer with documented MMR deficiency.

Target Accrual

168

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Patient Study Webpage

There is no available patient study webpage available for this trial at this time.