drugset / Trial / NCT05943106
BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bacillus Calmette-Guerin (BCG) | Unknown | — | Other |
| Subject | Durvalumab | Monoclonal antibody | — | Intravenous |