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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507684-19-00

Acronym

42756493BLC3004

Enrollment

201

Registered

2024-06-11

Start date

2024-07-24

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

FGFR+ Intermediate-risk Non-muscle Invasive Bladder Cancer

Brief summary

DFS will be measured as the time from randomization to the date of the first documented recurrence of NMIBC of any grade, disease progression, or death due to any cause, whichever occurs first

Interventions

DRUGMITOMYCIN

DRUGJNJ-42756493

DRUGGEMCITABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
DFS will be measured as the time from randomization to the date of the first documented recurrence of NMIBC of any grade, disease progression, or death due to any cause, whichever occurs first	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Ireland, Italy, Poland, Spain

Outcome results

None listed

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