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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519493-39-00

Acronym

42756493BLC3005

Enrollment

Registered

2025-11-03

Start date

2025-12-09

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk Non-muscle-invasive Bladder Cancer with Susceptible FGFR Alterations

Brief summary

DFS

Interventions

DRUGJNJ-42756493

DRUGGEMCITABINE

DRUGMITOMYCIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
DFS	—

Countries

Belgium, France, Germany, Greece, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026