NCT07207824

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

HERO: 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 This Phase 3, open-label, randomized, controlled clinical trial will enroll approximately 182 patients, who will be assigned in a 1:1 ratio to one of two treatment groups: Group A: Disitamab Vedotin plus BCG (induction and maintenance therapy) Group B: BCG alone (induction and maintenance therapy) The study is designed to demonstrate the superiority of Disitamab Vedotin combined with BCG (during both induction and maintenance phases) over BCG alone in prolonging event-free survival (EFS) among BCG-naïve participants with high-risk, HER2-expressing non-muscle invasive bladder cancer.

Conditions

• Bladder (Urothelial, Transitional Cell) Cancer
• NMIBC

Interventions

Type	Name	Description
DRUG	Active Comparator: BCG induction and maintenance	Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer Other Names: BCG
DRUG	DV + BCG induction and maintenance	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

Timeline

• Start date: 2025-12-01
• Primary completion: 2030-06-01
• Completion: 2030-12-01
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

1 site across 1 country: China