NCT06211764

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, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Non-Muscle Invasive Bladder Neoplasms

Interventions

Type	Name	Description
DRUG	TAR-200	Participants will receive TAR-200 intravesically.
DRUG	Mitomycin C	Participants will receive MMC intravesically.
DRUG	Gemcitabine	Participants will receive gemcitabine intravesically.

Timeline

• Start date: 2024-04-09
• Primary completion: 2030-11-27
• Completion: 2031-04-14
• First posted: 2024-01-18
• Last updated: 2026-04-13

Locations

123 sites across 14 countries: United States, Argentina, Belgium, Brazil, China, France, Germany, Italy, Japan, Poland, Romania, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study