Study Title
A phase III, open-label, controlled, multi-center, global study of first-line MEDI4736 monotherapy and MEDI4736 in combination with tremelimumab versus standard of care chemotherapy in patients with unresectable stage IV urothelial bladder cancer
Malignancy
Bladder Cancer, First Line Bladder Cancer, Urothelial Cancer, Transitional Cell Carcinoma of Bladder
Investigational Agent
Durvalumab (MEDI4736) and Tremelimumab
Drug Class
Anti PD-L1 and Anti-CTLA-4
Key Eligibility Criteria Details
- Unresectable Stage IV transitional cell carcinoma of the urothelium
- No previous treatment in metastatic setting
- PD-L1 status to be determined centrally prior to randomization
- No prior anti-CTLA or anti PD-1 agents
- No CNS involvement
- No active or prior autoimmune disease
- No HIV, HBV, HCV
Objective
Primary- PFS: Secondary- PFS for PD-L1neg pts: OS, ORR, QOL, PK