Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Recruiting now · Phase 2
Conditions studied: Muscle-invasive Bladder Cancer
In brief
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.
Key facts
- Study ID
- NCT06511648
- Run by
- Spanish Oncology Genito-Urinary Group
- People needed
- 90
- Starts
- 2023-03-07
- Expected to finish
- 2029-10-01
- Last updated by the study team
- 2025-12-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
- Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic therapy.
- Prior systemic therapy, radiation therapy, or surgery for bladder cancer
Where it is running
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom (enrolling)
- The Royal Marsden NHS Foundation Trust — London, United Kingdom (enrolling)
- Barts Health NHS Trust — London, United Kingdom (enrolling)
- Charing Cross Hospital — London, United Kingdom (enrolling)
- CLCC Jean Perrin — Clermont-Ferrand, France (enrolling)
- Institut Mutualiste Montsouris — Paris, France (enrolling)
- IUCT — Toulouse, France (enrolling)
- Institut Gustave Roussy — Villejuif, France (enrolling)
- IRCCS San Raffaele Hospital and Scientific Institute — Milan, Italy (enrolling)
- Ospedale Molinette — Turin, Italy (enrolling)
- Hospital Clínic De Barcelona — Barcelona, Catalonia, Spain (enrolling)
- Hospital De Sabadell (Parc Taulí) — Barcelona, Catalonia, Spain (enrolling)
- Complexo Hospitalario Universitario A Coruña — A Coruña, Galicia, Spain (enrolling)
- Hospital Universitario Lucus Augusti — Lugo, Galicia, Spain (enrolling)
- Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
- Hospital Universitario de Toledo — Toledo, Spain (enrolling)
- Fundación Instituto Valenciano De Oncología — Valencia, Spain (enrolling)
- Hospital Clínico Universitario De Valladolid — Valladolid, Spain (enrolling)
- Hospital Universitario Miguel Servet — Zaragoza, Spain (enrolling)
- CLCC Léon Bérard — Lyon, France
- ICO l' Hospitalet — Barcelona, Spain
- A.O. Ordine Mauriziano, Ospedale Umberto I — Turi, Italy
- University Hospitals of Morecambe Bay NHS Foundation Trust — Lancaster, United Kingdom
Full record on ClinicalTrials.gov
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