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A Phase 2 Study of Check Point Inhibitor, Durvalumab (MEDI4736) for Bacillus Calmette-Guérin (BCG) Refractory Urothelial Carcinoma in Situ (CIS) of the Bladder
The purpose of this study is to test if an experimental drug called Durvalumab (Medi4736) given by intravenous (IV) infusion is effective in treating carcinoma in situ (CIS) of the bladder that no longer responds to Bacillus Calmette-Guérin (BCG) and to collect information on the safety of these drugs and whether they cause any side effects.
Primary Objective: To evaluate whether Durvalumab can improve complete response rate at month 6 to 40% or higher. Secondary Objectives: To evaluate whether Durvalumab can improve the response rate at year 2 to 30% or higher. To assess the safety and tolerability of Durvalumab at 1500 mg Q4W IV infusion for 12 months. Exploratory Objectives: Correlate PD-L1 expression in urothelial carcinoma, tumor infiltrating T cells, mononuclear cells in bladder biopsies or TURBT samples with response to Durvalumab. Correlate chromosomal abnormalities detected by UroVysion urine test with response to Durvalumab.