drugset / Trial / NCT05714202
A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).
Timeline
- Start
- 2023-03-23
- Primary completion
- 2029-09-18
- Completion
- 2029-09-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bacillus Calmette-Guerin | Unknown | — | Other |
| Subject | Cetrelimab | Monoclonal antibody | — | — |
| Subject | TAR-200 | Other / unclassified | — | Other |