NRG-GY035 for PMMR, TP53 mutated advanced or recurrent endometrial cancer - Clinical Trial
What is the 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.
This study is for people who have a type of cancer called endometrial cancer, which starts in the lining of the uterus. The cancer must have certain features, including a specific change in a gene called TP53. It must also be a type called MMR proficient, which means the cancer cells repair themselves in a certain way. Researchers want to focus on this specific group to better understand the disease and improve treatment options.
Who Can Participate in the Study?
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.
What is Involved?
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.
Study Details
