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Active Not Recruiting
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
Conditions: Urothelial Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 629
Sponsor: Janssen Research & Development, LLC
Location: Alaska Urological Institute dba Alaska Clinical Research Center Anchorage Alaska
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).
Eligibility Criteria
Inclusion Criteria:
* Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than \[\
Source: ClinicalTrials.gov (NCT03390504). StuddyBuddy aggregates publicly available trial information.