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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 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.

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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).

Conditions Studied

Non-Muscle Invasive Bladder Neoplasms

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

FieldValue
Enrollment Target 220 participants
Start Date 2025-09-10
Est. Completion 2032-03-16
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

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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, categorized as Phase 3. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 6 other Non-Muscle Invasive Bladder Neoplasms trials with a reported enrollment target (21% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.