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New treatment option for Bladder (Urothelial, Transitional Cell) Cancer
Official title DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC
ClinicalTrials.gov ID: NCT07207824
What this study is testing
What is Active Comparator: BCG induction and maintenance?
Active Comparator: BCG induction and maintenance is an investigational medicine, being studied as a potential treatment for bladder (urothelial, transitional cell) cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- Histologically confirmed high-risk, non-muscle-invasive urothelial carcinoma of the bladder (UCC) (with \>50% urothelial carcinoma as the predominant...
- Complete resection of all Ta/T1 papillary lesions (including patients with concomitant CIS). The most recent Transurethral Resection of Bladder Tumor...
- 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.
You likely can't join if
- Histologically confirmed evidence of muscle-invasive (T2 or higher), locally advanced, or metastatic urothelial carcinoma, or the presence of...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.