drugset / Trial / NCT07726992
A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)
Timeline
- Start
- 2026-08-25
- Primary completion
- 2029-12
- Completion
- 2030-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SHR-1501 | Unknown | — | Intrathecal |
| Background | Bacillus Calmette-Guérin | Vaccine | — | — |