NRG-GY025 Endometrial Cancer

What is the Purpose of this Study?

We are doing this study to find out if the study drugs nivolumab and ipilimumab are a safe and effective option for people who have endometrial cancer that does not respond to standard treatment and/or has spread to other parts of the body. We want to compare the results of using these 2 drugs together versus using nivolumab alone.

What is the Condition Being Studied?

Recurrent or Metastatic Endometrial Cancer

Who Can Participate in the Study?

Women ages 18+ who:
- Are diagnosed with recurrent or metastatic endometrial cancer
- Have not received more than 2 previous lines of therapy

For more information about who can join this study, contact the study team at nick.jeffries@duke.edu.

Age Group
Adults

What is Involved?

If you decide to participate in this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:

- Group 1: You will get the study drugs nivolumab and ipilimumab. You will get the nivolumab through a vein in the arm or through a port on the first day of each cycle. Each cycle lasts 3 weeks. You will also get the drug ipilimumab through a vein in the arm or through a port on the first day of every other cycle (every 6 weeks).

- Group 2: You will receive the study drug nivolumab. You will get this drug through a vein in the arm or through a port on the first day of each cycle.

Study Details

Full Title
NRG-GY025: NRG-GY025, A Randomized Phase II Trial of Nivolumab and Ipilimumab compared to Nivolumab Monotherapy in Patients with Deficient Mismatch Repair System Recurrent Endometrial Carcinoma --Safety Lead-in Portion
(NCT # 05112601)
Principal Investigator
Professor of Obstetrics and Gynecology
Protocol Number
IRB: PRO00113684
NCT: NCT05112601
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL