drugset / Trial / NCT07151560
Efficacy and Safety of Two Bladder-preserving Treatment Durations With Disitamab Vedotin Plus Toripalimab Combination in Her2-expressing Muscle-invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS (BI-DFS) and safety.
Timeline
- Start
- 2025-08-30
- Primary completion
- 2027-08-30
- Completion
- 2030-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Disitamab Vedotin | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 3 mg/kg | Intravenous |
Indications
No indication recorded.