drugset / Trial / NCT05943106

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

NCT05943106

Phase 3 Active not recruiting 100 enrolled AstraZeneca Parexel · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-08-11
Primary completion
2025-06-16
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bacillus Calmette-Guerin (BCG) Unknown Other
Subject Durvalumab Monoclonal antibody Intravenous