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A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
NCT06919965 · View on ClinicalTrials.gov ↗
Study Summary
The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Mitomycin C
- DRUG TAR-210
Study Locations (20)
Ohio
- Dayton Physicians Network Urology — Centerville
- The Urology Group — Cincinnati
- Helios Clinical Research, LLC — Middleburg Heights
Pennsylvania
- MidLantic Urology — Bala-Cynwyd
- MidLantic Urology — Lancaster
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center — Pittsburgh
Texas
- Urology Austin — Austin
- Urology San Antonio PA dba USA Clinical Trials — San Antonio
Colorado
- Colorado Clinical Research — Lakewood
Georgia
- Georgia Urology — Atlanta
Illinois
- Associated Urological Specialists — Chicago Ridge
Indiana
- Urology of Indiana — Carmel
Massachusetts
- Greater Boston Urology — Plymouth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2025-09-10 |
| Est. Completion | 2032-03-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06919965
The ClinicalTrials.gov registry entry for NCT06919965 describes a study currently listed as 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 220 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: NCT06919965 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Ohio, Pennsylvania, Texas. 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 NCT06919965 about?
NCT06919965 is a clinical study titled "A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer". The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-2...
What is the current status of trial NCT06919965?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2025-09-10. Estimated completion is 2032-03-16.
What conditions does trial NCT06919965 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 NCT06919965?
The interventions under investigation include: Gemcitabine (DRUG), Mitomycin C (DRUG), TAR-210 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06919965?
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 NCT06919965 being conducted?
This trial has 20 study locations across Colorado, Georgia, Illinois, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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