A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected 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-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
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.
Inclusion Criteria:
Exclusion Criteria:
Anchorage, Alaska 99503, United States
Córdoba, C5000, Argentina
Goiânia, 74605-070, Brazil
São José do Rio Preto, 15090-000, Brazil
Braunschweig, 38126, Germany
Budapest, 1122, Hungary
Petach Tikvah, 49100, Israel
Alessandria, 15121, Italy
Brescia, 25123, Italy
Torrette Di Ancona, 60126, Italy
Kita Gun, 761 0793, Japan
Shinjuku-ku, 162-8666, Japan
Warsaw, 02-781, Poland
Kuzmolovsky, 188663, Russia
Nizhny Novgorod, 603109, Russia
Saint Petersburg, 197758, Russia
Niao-Sung Hsiang, 833, Taiwan
Adana, 01120, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
Dnipro, 49100, Ukraine
Dnipro, 49102, Ukraine
Kharkiv, 61037, Ukraine
Kyiv, 03115, Ukraine
Lviv, 79010, Ukraine
Zaporizhzhya, 69600, Ukraine