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

Not Applicable

Not yet recruiting

• Conditions: Bladder (Urothelial, Transitional Cell) Cancer; NMIBC
• Interventions: Drug: DV + BCG induction and maintenance

• Registration Number: NCT07207824
• Lead Sponsor: Fudan University

Brief 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-28
• Study First Submitted QC: 2025-09-28
• Last Update Submitted: 2025-09-28
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06
• Study Start: 2025-12-01
• Primary Completion: 2030-06-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DV + BCG	DV + BCG induction and maintenance	Disitamab Vedotin + BCG induction and maintenance

Primary Outcome Measures

Name	Time	Method
Event free survival	55 months after first participant randomized	Event free survival is defined as the time from randomization to date of EFS event.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Randomization up to 60 months from last participant randomized	Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Complete response rate at 6m/12m in participants with CIS at randomization	Randomization up to 12 months from last participant randomized	Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.
Disease-specific survival	Randomization up to 60 months from last participant randomized	Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.
Health-related quality of life as measured by EORTC QLQ-C30	Randomization up to 60 months from last participant randomized	Health-related quality of life as measured by EORTC QLQ-C30
Health-related quality of life as measured by EORTC QLQ-NMIBC24	Randomization up to 60 months from last participant randomized	EORTC-QLQ-NMIBC24 has 24 items which can be grouped into 6 subscales: urinary symptoms (7 items), malaise (2 items), future worries (4 items), bloating/flatulence (2 items), sexual functioning (2 items), and male sexual issues (2 items). The NMIBC24 also assesses intravesical treatment, female sexual issues, sexual intimacy, risk of contaminating a partner, and sexual enjoyment (1 item each).

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai Municipality, China