Status:
Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Janssen Research & Development, LLC
Enrollment:
631
Study Design:
Participants will be screened based on Fibroblast Growth Factor Receptor Inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled.
Cohort 1: Erdafitinib vs Vinflunine or Docetaxel
Cohort 2: Erdafitinib vs. Pembrolizumab
Rationale:
This trial will evaluate erdafitinib compared with chemotherapy or immunotherapy in patients with advanced urothelial cancer and FGFR gene aberrations. This is evaluating erdafitinib in the first line setting.
Endpoints:
Primary Endpoint: Overall Survival (OS)
Secondary Endpoints: Time Frame: Approximately up to 3 years ; Progression-free Survival (PFS), Overall Response Rate (ORR), Patient-Reported Health Status, Patient-Global Impression of Severity (PGIS) Score, the Visual Analog Scale (VAS) of the EQ-5D-5L, Utility Scale of the EQ-5D-5L, Duration of Response (DOR), Safety, Oral Clearance (CL/F) of Erdafitinib, AUC of Erdafitinib
