Clinical Trial

Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations

Study acronym: SOGUG-NEOWIN
Recruiting Phase 2
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Record status
This record was last updated December 19, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express Fibroblast Growth Factor Receptor (FGFR )gene alterations and are ineligible for or refuse cisplatin based neoadjuvant chemotherapy.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-07-19; most recent amendment 2025-12-12.
Trial Details
NCT Number NCT06511648
Lead Sponsor Spanish Oncology Genito-Urinary Group
Collaborators: Janssen-Cilag Ltd., Pivotal S.L.
Conditions Muscle-invasive Bladder Cancer
Enrollment 90 participants
Start Date 2023-03-07
Primary Completion 2026-07 (estimated)
Study Completion 2029-10 (estimated)
Updated on ClinicalTrials.gov 2025-12-19