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.
Who Can Participate?
Eligibility
Women ages 18+ who:
- Are diagnosed with recurrent or metastatic endometrial cancer
- Have not received more than 2 previous lines of therapy
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
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)
(NCT # 05112601)
Principal Investigator
Angeles
Secord
Protocol Number
PRO00113684
NCT ID
NCT05112601
Phase
II
Enrollment Status
Open to Enrollment