Disitamab Vedotin plus BCG vs BCG alone in HER2-expressing high-risk NMIBC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, open-label, randomized trial compares disitamab vedotin plus BCG to BCG alone in adults with high-risk, non-muscle-invasive bladder cancer that expresses HER2. Approximately 182 patients are randomized 1:1 to receive induction and maintenance therapy with either DV+BCG or BCG alone. The goal is to see if the combination prolongs event-free survival compared with BCG alone. Eligibility includes prior complete resection, HER2 positivity by local testing, and no plan for radical cystectomy. The study is conducted at Fudan University Shanghai Cancer Center and is sponsored by Fudan University.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Age ≥ 18 years.
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

1. 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.
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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Yi jun Shen, M.D.
• Email: yijunshen@urocancer.org
• Phone: 862164175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.