“A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations”
The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
Drug - Erdafitinib
Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
Drug - Vinflunine
Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.
Drug - Docetaxel
Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.
Drug - Pembrolizumab
Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.
Device - Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
FGFRi CTA will be used to determine molecular eligibility.
A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations