Erdafitinib alone or with cetrelimab before surgery for bladder cancer
Tests erdafitinib, alone or with cetrelimab, before surgery in adults with muscle-invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Key facts
- Where
- A Coruña, Barcelona, L'Hospitalet de Llobregat, Lugo, Madrid, Sabadell, Toledo, Valencia, Valladolid, and Zaragoza, SpainSee the 10 sites
- Phase
- Phase 2
Where in Spain
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpainNo longer taking part
- Hospital Clinic de BarcelonaBarcelona, SpainNo longer taking part
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainNo longer taking part
- Hospital Universitario Lucus AugustiLugo, SpainNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpainNo longer taking part
- Parc Tauli Hospital UniversitariSabadell, SpainNo longer taking part
- Hospital Universitario de ToledoToledo, SpainNo longer taking part
- Fundación Instituto Valenciano de OncologíaValencia, SpainNo longer taking part
- Hospital Clínico Universitario de ValladolidValladolid, SpainNo longer taking part
- Hospital Universitario Miguel ServetZaragoza, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Spanish Oncology Genito-Urinary Group
- Trial code
- NCT06511648EU 2024-512573-27-01
- Record updated
- 19 December 2025
- Original description
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.Read full original descriptionShow less
A Phase 2, Open-label, Multi-centre, Multi-national Interventional Trial to Evaluate the Efficacy and Safety of Erdafitinib (ERDA) Monotherapy and Erdafitinib (ERDA) and Cetrelimab (CET) Combination as Neoadjuvant Treatment in Cisplatin-ineligible Patients With Muscle-invasive Bladder Cancer (MIBC) Whose Tumours Express Fibroblast Growth Factor Receptor ( FGFR ) Gene Alterations
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.
Inclusion: Written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the study; Histologically confirmed diagnosis of MIBC (Stage T2-4a N0/N1 M0) obtained via a diagnostic or maximal Transurethral Resection of Bladder Tumor (TURBT) performed no later than 3 months prior to start the screening visit; Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site; Age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Decline or ineligible ("unfit") for cisplatin-based chemotherapy; Presence of a selected FGFR alteration on analysis of tumour biopsy; Adequate organ function; No other malignancy; Willingness to avoid pregnancy or fathering children.
Exclusion: Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic therapy; Prior systemic therapy, radiation therapy, or surgery for bladder cancer; Clinical evidence of N2-N3 tumours or metastatic bladder cancer; Has tumour with any neuroendocrine or small cell component; Patients who are not considered fit for cystectomy or reject cystectomy.