🏛️ Verified NIH Record • Updated 2026-08-27

A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer (NCT03473743)

A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.

Who can join: Review the eligibility criteria below.

Location: Rocky Mountain Cancer Centers — Aurora, Colorado

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (127 Sites)

Showing the first 25 of 127 sites.

  • Rocky Mountain Cancer Centers — Aurora, Colorado
  • Norton Cancer Institute — Louisville, Kentucky
  • Maryland Oncology Hematology, PA — Rockville, Maryland
  • Hackensack University Medical Center — Hackensack, New Jersey
  • Weill Cornell Medical College - NY Presbyterian Hospital — New York, New York
  • White Plains Hospital Center for Cancer Care — White Plains, New York
  • Levine Cancer Institute, Carolinas HealthCare System — Charlotte, North Carolina
  • Toledo Clinic Cancer Centers — Toledo, Ohio
  • Penn State Hershey Cancer Institute — Hershey, Pennsylvania
  • Texas Oncology, P.A. — Fort Worth, Texas
  • The University of Texas MD Anderson Cancer Center — Houston, Texas
  • Virginia Oncology Associates — Norfolk, Virginia
  • Brest Regional Oncology Dispensary — Brest,
  • Grodno University Hospital — Grodno,
  • Gomel Regional Clinical Oncology Dispensary — Homyel,
  • State Institution N.N. Alexandrov Republican Scientific and — Lesnoy,
  • Minsk city Clinical Oncological Dispensary — Minsk,
  • Mogilev Regional Hospital — Mogilev,
  • Vitebsk Regional Clinical Hospital — Vitebsk,
  • ULB Hôpital Erasme — Brussels,
  • Cliniques Universitaires Saint Luc — Brussels,
  • Jolimont — Haine-Saint-Paul,
  • Az Groeninge — Kortrijk,
  • CHU de Liège - Domaine Universitaire du Sart Tilman — Liège,
  • AZ Nikolaas - Campus Sint-Niklaas Moerland — Sint-Niklaas,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗