Spots Global Cancer Trial Database for BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants

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Trial Identification

Brief Title: BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants

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 Cancer Participants (PATAPSCO)

Study ID: NCT05943106

Conditions

Non-Muscle- Invasive Bladder Cancer

Interventions

Durvalumab

BCG

Study Description

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.

Detailed Description: This is an open-label, single-arm, multi-center, Phase IIIb US study exploring the combination of durvalumab and BCG (induction and maintenance) in participants with high-risk NMIBC. Each participant will have screening activities up to 4 weeks before initiation of study intervention, receive study intervention for up to 24 months, followed by 3 months safety follow-up. Participants will continue to be followed up for survival until 2 years from the date of treatment initiation of the last participant enrolled in this study (approximately 42 months after first participant enrolled).