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.
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.
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.
Spanish Oncology Genito-Urinary Group
Lead sponsor
Janssen-Cilag Ltd.
Collaborator
Pivotal S.L.
Collaborator