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

Prior treatment

• Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic therapy.
• Prior systemic therapy, radiation therapy, or surgery for bladder cancer

Other illness

• Clinical evidence of N2-N3 tumours or metastatic bladder cancer.

Other

• Has tumour with any neuroendocrine or small cell component.
• Patients who are not considered fit for cystectomy or reject cystectomy.

• 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