Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

Inclusion Criteria: * Histologically documented metastatic or unresectable urothelial carcinoma. Both transitional cell and mixed transitional cell histologies are allowed, provided urothelial component is ≥ 50%. * At least 1 measurable target lesion per RECIST v1.1. * Must be ineligible to receive cisplatin. Patients ineligible for any platinum-based chemotherapy are allowed. * Known FGFR3 mutation or rearrangement confirmed by the central laboratory prior to randomization. * Central laboratory test result of PD-L1 status is mandatory at screening. * Have received no prior systemic chemotherapy for metastatic or unresectable urothelial carcinoma (except adjuvant platinum-based chemotherapy following radical cystectomy, with recurrence \> 12 months from completion of therapy, or neo-adjuvant platinum-based chemotherapy, with recurrence \> 12 months since completion of therapy). * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Prior receipt of a selective FGFR inhibitor for any indication or reason. * Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor. * Receipt of anticancer medications or investigational drugs for unresectable and/or metastatic disease. * Concurrent anticancer therapy, except for treatment allowed per protocol. * Has disease that is suitable for local therapy administered with c…