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
629 patients around the world
Available in Argentina, Brazil, Mexico
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.
Janssen Research & Development, LLC
14Research sites
629Patients around the world
This study is for people with
Urothelial cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires