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NCT06211764 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Non-Muscle Invasive Bladder Neoplasms, sponsored by Janssen Research & Development.

Active
Registry status
Phase 3
Development phase
272
Enrollment target
20
Study locations

NCT06211764: Active Phase 3 study of Non-Muscle Invasive Bladder Neoplasms, sponsored by Janssen Research & Development.

NCT06211764 is a Phase 3 study of Non-Muscle Invasive Bladder Neoplasms that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 272 participants, roughly in line with the 268-participant average among 6 other Non-Muscle Invasive Bladder Neoplasms trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06211764, a Phase 3 study of Non-Muscle Invasive Bladder Neoplasms, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
272 participants
Enrollment target
20
Study locations

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.

Primary Outcome

DFS will be measured as the time from randomization to the time of the first recurrence of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) \[high grade (HG) Ta, any T1 or carcinoma in situ (CIS)\], progression, or death due to any cause, whichever occurs first.

Conditions Studied

Non-Muscle Invasive Bladder Neoplasms

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

FieldValue
Enrollment Target 272 participants
Start Date 2024-04-09
Est. Completion 2031-04-14
Phase Phase 3
Janssen Research & Development

593 total trials

What the registry record for NCT06211764 still lists

NCT06211764 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 268-participant average among 6 other Non-Muscle Invasive Bladder Neoplasms trials with a reported enrollment target.

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.

NCT06211764 names 20 study sites across 13 states, led by California, Illinois, Indiana.

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.

What interventions are being tested in trial NCT06211764?

The interventions under investigation include: Gemcitabine (DRUG), Mitomycin C (DRUG), TAR-200 (DRUG).

Who is sponsoring clinical trial NCT06211764?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

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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Related registry views

Source: ClinicalTrials.gov NCT06211764, the US trial registry maintained by the National Library of Medicine. NCT06211764 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.