Full TitlePAC PROTOCOL IIT: A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab in Metastatic, Non-Transitional Cell Carcinoma of the Urothelial Tract
Durvalumab and tremelimumab are immunotherapy drugs. They boost the power of the immune system to recognize and kill cancer cells by inhibiting proteins that normally put the brakes on the immune response. Durvalumab targets the PD-L1 protein, while tremelimumab inhibits the CTLA-4 protein.
The combination of these two drugs may work better than either drug alone to eliminate cancer cells. Immunotherapies have been shown to help patients with several different kinds of cancer, including transitional cell carcinoma of the urinary tract (the most common form of urinary tract cancer). Researchers believe that immunotherapies may also help patients with other rare forms of cancer of the urinary tract, such as adenocarcinoma, squamous cell carcinoma, or small cell/neuroendocrine carcinoma.
The purpose of this study is to assess the safety and effectiveness of durvalumab and tremelimumab in patients with metastatic non-transitional cell urothelial cancer. 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 metastatic non-transitional cell urothelial cancer.
- Patients with small cell cancers must have experienced cancer growth after at least one prior regimen of therapy. No prior therapy is required for patients with squamous cell cancers or adenocarcinoma. There is no limit on the number of prior therapies.
- At least 2 weeks must pass since prior radiation therapy, 3 weeks since previous chemotherapy, and 4 weeks since major surgery and entry into the study.
- 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 patients age 18 and older.
For more information and to inquire about eligibility for this study, please contact Dr. Samuel Funt at 646-888-4770.