DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC
A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined With Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients With HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer
Fudan University
182 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer Other Names: BCG
Drug: Disitamab vedotin(RC48) •An antibody-drug conjugates (ADCs) targeting HER2, has been approved in China for chemotherapy-refractory advanced UC with HER2-expression. Other Names: • RC48, DV Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer Other Names: BCG
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07207824