Full TitleIIT: A Phase 2 Trial of Durvalumab [MEDI4736](anti-PD-L1 Antibody) With or Without Tremelimumab (anti-CTLA-4 antibody) in Patients with Persistent or Recurrent Endometrial Carcinoma and Endometrial Carcinosarcoma
The purpose of this study is to assess the safety and effectiveness of the immunotherapy drug durvalumab alone and in combination with tremelimumab, another immunotherapy drug, in women with recurrent or persistent endometrial carcinoma or carcinosarcoma.
Durvalumab is designed to boost the body’s immune system by targeting a protein on tumor cells called PD-L1. PD-L1 normally maintains the balance of the immune system. In cancer, PD-L1 helps tumors escape detection and destruction by the immune system. Durvalumab may increase the immune system’s ability to identify and destroy cancer cells. It is used to treat bladder cancer; its use in this study is investigational.
Tremelimumab is an investigational drug that blocks CTLA4, a protein found on cells of the immune system. CTLA4 puts the brakes on the immune response and may prevent immune cells from attacking cancer cells. Tremelimumab prevents this from happening, potentially enhancing the immune response against the cancer.
In this study, patients will receive either durvalumab alone or durvalumab and tremelimumab. Both drugs are given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have endometrial carcinoma or carcinosarcoma that has come back or continued to grow despite prior therapy that included a platinum-containing drug.
- At least 3 weeks must pass since the completion of previous chemotherapy and 4 weeks since prior radiation therapy and entry into the study.
- Patients may not have received previous immunotherapy.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for women ages 18 and older.