Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
NCT06211764 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Mitomycin C
- DRUG TAR-200
Study Locations (20)
California
- Genesis Research LLC 1 — Los Alamitos
- USC Norris Comprehensive Cancer Center — Los Angeles
- University of California Irvine Medical Center — Orange
- University of California San Francisco — San Francisco
- Genesis Research LLC — Torrance
Illinois
- Northwestern University — Chicago
- UroPartners — Chicago Ridge
Indiana
- Urology of Indiana — Carmel
- First Urology, PSC — Jeffersonville
Ohio
- The Urology Group — Cincinnati
- Central Ohio Urology Group — Gahanna
Arkansas
- Arkansas Urology — Little Rock
Colorado
- Colorado Clinical Research — Lakewood
Florida
- Florida Urology Partners — Riverview
Kansas
- Wichita Urology Group — Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2024-04-09 |
| Est. Completion | 2031-04-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06211764
The ClinicalTrials.gov registry entry for NCT06211764 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 272 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-Muscle Invasive Bladder Neoplasms appearing as the primary indexed condition, and to 3 interventions — of which Gemcitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06211764 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Illinois, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06211764 about?
NCT06211764 is a clinical study titled "A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)". The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC),...
What is the current status of trial NCT06211764?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 272 participants. The study started on 2024-04-09. Estimated completion is 2031-04-14.
What conditions does trial NCT06211764 study?
This clinical trial studies the following conditions: Non-Muscle Invasive Bladder Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06211764?
The interventions under investigation include: Gemcitabine (DRUG), Mitomycin C (DRUG), TAR-200 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06211764?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06211764 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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