drugset / Trial / NCT07207824
DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC
Phase 3
Not yet recruiting
182 enrolled
Fudan University
Fujian Cancer Hospital · collabNingbo Medical Center Lihuili Hospital · collabTenth People's Hospital of Tongji Univeristy · collabXinhua Hospital, Shanghai Jiao Tong University School of Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.
Timeline
- Start
- 2025-12-01
- Primary completion
- 2030-06-01
- Completion
- 2030-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Disitamab Vedotin | Monoclonal antibody | — | — |
| Comparator | Bacillus Calmette-Guérin | Vaccine | — | — |