A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510306-40-00

Acronym

42756493BLC2003

Enrollment

Registered

2024-05-13

Start date

2020-08-11

Completion date

2025-02-27

Last updated

2025-01-22

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

Conditions

Cohort 1 and 2: High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or Fusions Cohort 3 Intermediate Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or Fusions

Brief summary

Recurrence-free survival (RFS)

Interventions

DRUGGemcitabine 38 mg/ml Concentrate for Solution for Infusion

DRUGJNJ-42756493

DRUGGemcitabine 2 g Powder for Solution for Infusion

DRUGMitomycin medac 1 mg/ml Pulver zur Herstellung einer Injektions- bzw. Infusionslösung oder einer Lösung zur intravesikalen Anwendung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence-free survival (RFS)	—

Countries

France, Germany, Poland

Outcome results

None listed

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