Purpose of this Study
This study has three groups. In each group, people receive medicines used to treat this type of cancer through a vein every three weeks for several treatment cycles. In the first group, people receive common cancer medicines along with another medicine called pembrolizumab. After this part, they continue with pembrolizumab alone for a longer time, with treatments given every six weeks for up to about two years.
In another group, people receive a study medicine called bevacizumab together with standard cancer treatments. These medicines are also given through a vein during regular treatment cycles. The study is designed to compare these different treatment plans to see which works best and is safest for patients.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have endometrial cancer that is advanced, has spread, or has come back after treatment. The cancer must be confirmed by lab testing and must meet specific types and features, including certain gene changes that doctors can test for.
If the cancer can be measured on scans, it must be large enough for doctors to track during the study. People may have had some treatments before, such as chemotherapy, radiation, or hormone therapy, but there must be enough time since those treatments ended. They cannot have had certain newer immune or targeted treatments before.
Participants must be healthy enough to take part in the study and able to do most daily activities. They cannot be pregnant or breastfeeding. Patients with treated brain disease may be able to join if it is stable.
Age Range
18-100
Sex/Genders
Female (cisgender)
Transgender male
Looking for Healthy Participants
No
What is Involved?
Description
This study is comparing two ways to treat this type of cancer. One group will receive the usual treatment. The other group will receive the usual treatment plus another medicine called bevacizumab. Researchers want to learn if adding bevacizumab can help shrink the cancer or stop it from coming back.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Protocol NRG-GY035, A Randomized Phase III Trial of Carboplatin, Paclitaxel, and Pembrolizumab versus Carboplatin, Paclitaxel, and Bevacizumab versus Carboplatin, Paclitaxel, Pembrolizumab and Bevacizumab in the Treatment of PMMR, TP53 Mutated Advanced or Recurrent Endometrial Cancer (NCT07198074)
Principal Investigator
Jennifer
McNally
Protocol Number
PRO00119814
NCT ID
NCT07198074
Phase
III
Enrollment Status
Open to Enrollment