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-programmed death ligand 1(PD-[L]1)
agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
Additional locations may be listed on ClinicalTrials.gov for NCT03390504.
See trial information on ClinicalTrials.gov for a list of participating sites.
A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or
vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced
urothelial cancer and selected FGFR aberrations who have progressed on or 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). It will consist of
screening, treatment phase (from randomization until disease progression, intolerable
toxicity, withdrawal of consent or decision by investigator to discontinue treatment,
post-treatment follow-up (from end-of-treatment to participants death, withdraws consent,
lost to follow-up study completion for the respective cohort, whichever comes first). The
study will have long term extension (LTE) period after clinical cutoff date is achieved
for final analysis of each cohort and participants eligible in the opinion of the
investigator, will continue to benefit from the study intervention. Efficacy,
pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and
safety will be assessed.
Lead OrganizationJanssen Pharmaceuticals