Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
182 participants
INTERVENTIONAL
2025-12-01
2030-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DV + BCG
Disitamab Vedotin + BCG induction and maintenance
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
BCG
BCG induction and maintenance
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. 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.
4. HER2 expression (IHC 1+/2+/3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.
5. Unwillingness or ineligibility to undergo radical cystectomy.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
7. Signed informed consent form (ICF).
Exclusion Criteria
2. Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.
3. History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).
4. Prior therapy with any other type of HER2-targeted inhibitor.
5. Major surgery within 2 weeks prior to randomization.
6. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.
18 Years
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Fujian Cancer Hospital
OTHER_GOV
Tenth People's Hospital of Tongji Univeristy
UNKNOWN
Ningbo Medical Center Li Huili Hospital
UNKNOWN
Fudan University
OTHER
Responsible Party
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Ding-Wei Ye
Director of Urology
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RCVDUCIIR020-2
Identifier Type: -
Identifier Source: org_study_id
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