NCT06319820

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 641 (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 between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Conditions

• Non-Muscle Invasive Bladder Neoplasms

Interventions

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

Timeline

• Start date: 2024-04-18
• Primary completion: 2028-06-28
• Completion: 2032-12-31
• First posted: 2024-03-20
• Last updated: 2026-04-13

Locations

193 sites across 20 countries: United States, Argentina, Austria, Belgium, Brazil, China, Czechia, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Poland, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study