Sogug Neowin

1) 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. 

2) Histologically confirmed diagnosis of MIBC (Stage T2-4a N0/N1 M0) obtained via a diagnostic or maximal TURBT performed no later than 3 months prior to start the screening visit. 

3) Pure or predominant (≥50%) UC histology as determined at the local site. 

4) Age ≥ 18 years. 

5) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 

6) Decline or ineligible (“unfit”) for cisplatin-based chemotherapy 

7) Presence of a selected FGFR alteration on analysis of tumour biopsy 

8) Adequate organ function 

9) No other malignancy 

10) Willingness to avoid pregnancy or fathering children 

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

2) Has tumour with any neuroendocrine or small cell component. 

3) Patients who are not considered fit for cystectomy or reject cystectomy. 

4) Prior FGFR-targeted or antiPD1/PDL1 systemic therapy. 

5) Prior systemic therapy, radiation therapy, or surgery for bladder cancer 

Research Nurse: Hilary Thatcher

Administrator: research.oncology@mbht.nhs.uk