Clinical Trial

Treatment of Advanced Urothelial Cancer

Study Description

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).

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03390504

ParticipAid ID

QeZj2e