NCT06919965

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Non-Muscle Invasive Bladder Neoplasms

Interventions

Type	Name	Description
DRUG	TAR-210	TAR-210 will be administered intravesically.
DRUG	Mitomycin C	MMC will be administered intravesically.
DRUG	Gemcitabine	Gemcitabine will be administered intravesically.

Timeline

• Start date: 2025-09-10
• Primary completion: 2028-04-06
• Completion: 2032-03-16
• First posted: 2025-04-09
• Last updated: 2026-03-13

Locations

104 sites across 15 countries: United States, Argentina, Belgium, Brazil, China, France, Germany, Greece, Israel, Italy, Japan, Netherlands, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study