A Study to Evaluate Infigratinib to Treat Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness of infigratinib in approximately 218 adult subjects with invasive urothelial carcinoma with susceptible FGFR3 genetic alterations (mutations, and gene fusions or translocations [ie, rearrangements]; hereafter referred to collectively as "FGFR3 alterations") who are within 120 days following nephroureterectomy, distal ureterectomy, or cystectomy and ineligible for cisplatin-based (neo)adjuvant chemotherapy or with residual disease after neoadjuvant therapy.