drugset / Trial / NCT06211764
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.
Timeline
- Start
- 2024-04-09
- Primary completion
- 2030-11-27
- Completion
- 2031-04-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | — | Other |
| Comparator | Mitomycin C | Other / unclassified | — | Other |
| Subject | TAR-200 | Other / unclassified | — | Other |