DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC

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.

NCT Number	NCT07207824
Lead Sponsor	Fudan University
Conditions	Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
Enrollment	182 participants
Start Date	2025-12-01
Primary Completion	2030-06-01 (estimated)
Study Completion	2030-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-21