Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 1

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

NCT03473743 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Cetrelimab
  • DRUG Erdafitinib

Study Locations (20)

Other

  • 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

New York

  • Weill Cornell Medical College - NY Presbyterian Hospital — New York
  • White Plains Hospital Center for Cancer Care — White Plains

Texas

  • Texas Oncology, P.A. — Fort Worth
  • The University of Texas MD Anderson Cancer Center — Houston

Colorado

  • Rocky Mountain Cancer Centers — Aurora

Kentucky

  • Norton Cancer Institute — Louisville

Maryland

  • Maryland Oncology Hematology, PA — Rockville

New Jersey

  • Hackensack University Medical Center — Hackensack

North Carolina

  • Levine Cancer Institute, Carolinas HealthCare System — Charlotte

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2018-04-05
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

Janssen Research & Development

442 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03473743

The ClinicalTrials.gov registry entry for NCT03473743 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 4 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03473743 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03473743 about?

NCT03473743 is a clinical study titled "A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer". 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 a...

What is the current status of trial NCT03473743?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2018-04-05. Estimated completion is 2026-12-31.

What conditions does trial NCT03473743 study?

This clinical trial studies the following conditions: Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03473743?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Cetrelimab (DRUG), Erdafitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03473743?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03473743 being conducted?

This trial has 20 study locations across Colorado, Kentucky, Maryland, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial