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First received: July 05, 2023

Clinical Trial: BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants

Study Status: Completed

Recruit Status: RECRUITING

Condition: Non-Muscle- Invasive Bladder Cancer

Study Type: INTERVENTIONAL


Official Title: A Phase IIIb Open-Label, Single-Arm, Multi-Center, US Study of Bacillus Calmette-Guerin (BCG) Administered in Combination With Durvalumab in Adult BCG-naïve, High-risk Non-Muscle- Invasive Bladder Can

Brief Summary: The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (NMIBC), who have received no prior systemic therapy for NMIBC, and who are BCG-naïve.

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