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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

NCT03390504 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 629

Last updated 2026-05-11

Study results available
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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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-23
Primary Completion
2024-04-15
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03390504 on ClinicalTrials.gov