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NCT06919965 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
A Phase 3 study of Non-Muscle Invasive Bladder Neoplasms, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT06919965: Recruiting Phase 3 study of Non-Muscle Invasive Bladder Neoplasms, sponsored by Janssen Research & Development.
NCT06919965 is a Phase 3 study of Non-Muscle Invasive Bladder Neoplasms that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 220 participants, below the 277-participant average among 6 other Non-Muscle Invasive Bladder Neoplasms trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06919965, a Phase 3 study of Non-Muscle Invasive Bladder Neoplasms, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
DFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1 or carcinoma in situ \[CIS\]), progression, or death due to any cause, whichever occurs first.
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 |
What NCT06919965 shows while recruiting
NCT06919965 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 277-participant average among 6 other Non-Muscle Invasive Bladder Neoplasms trials with a reported enrollment target (21% lower).
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.
NCT06919965 names 20 study sites across 15 states, led by Ohio, Pennsylvania, Texas.
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.
What interventions are being tested in trial NCT06919965?
The interventions under investigation include: Gemcitabine (DRUG), Mitomycin C (DRUG), TAR-210 (DRUG).
Who is sponsoring clinical trial NCT06919965?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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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