NCT03390504

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

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 629 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Urothelial Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-03-23
• Primary completion: 2024-04-15
• Completion: 2026-12-31
• First posted: 2018-01-04
• Last updated: 2026-04-13
• Results posted: 2025-05-14

Locations

345 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study