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

NCT07207824 | Not Yet Recruiting Phase 3

• 1 other identifier: RCVDUCIIR020-2
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer; NMIBC

Keywords

NMIBC; disitamab vedotin; HER2; BCG

Outcome Measures

Primary Outcomes (1)

• Event free survival

  Event free survival is defined as the time from randomization to date of EFS event.

  55 months after first participant randomized

Secondary Outcomes (5)

• Overall Survival

  Randomization up to 60 months from last participant randomized

• Complete response rate at 6m/12m in participants with CIS at randomization

  Randomization up to 12 months from last participant randomized

• Disease-specific survival

  Randomization up to 60 months from last participant randomized

• 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-NMIBC24

  Randomization up to 60 months from last participant randomized

Study Arms (2)

DV + BCG

EXPERIMENTAL

Disitamab Vedotin + BCG induction and maintenance

Drug: DV + BCG induction and maintenance

BCG

ACTIVE COMPARATOR

BCG induction and maintenance

Drug: Active Comparator: BCG induction and maintenance

Interventions

Active Comparator: BCG induction and maintenance DRUG

Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer Other Names: BCG

BCG

DV + BCG induction and maintenance DRUG

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

DV + BCG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Histologically confirmed high-risk, non-muscle-invasive urothelial carcinoma of the bladder (UCC) (with \>50% urothelial carcinoma as the predominant histological component), defined by the presence of any of the following: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS).
• Complete resection of all Ta/T1 papillary lesions (including patients with concomitant CIS). The most recent Transurethral Resection of Bladder Tumor (TURBT) must have been performed within 12 weeks prior to randomization. A second TURBT was required if indicated per current local applicable guidelines.
• HER2 expression (IHC 1+/2+/3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.
• Unwillingness or ineligibility to undergo radical cystectomy.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
• Signed informed consent form (ICF).

You may not qualify if:

• Histologically confirmed evidence of muscle-invasive (T2 or higher), locally advanced, or metastatic urothelial carcinoma, or the presence of concurrent extravesical non-muscle-invasive urothelial carcinoma.
• Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.
• History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).
• Prior therapy with any other type of HER2-targeted inhibitor.
• Major surgery within 2 weeks prior to randomization.
• Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.

Sponsors & Collaborators

• Fudan University: lead
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Fujian Cancer Hospital: collaborator
• Tenth People's Hospital of Tongji Univeristy: collaborator
• Ningbo Medical Center Li Huili Hospital: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200230, China

Location

MeSH Terms

Conditions

Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Central Study Contacts

Yi jun Shen, M.D.

CONTACT

862164175590; yijunshen@urocancer.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urology

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)