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Active, not recruiting Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03473743

Public ClinicalTrials.gov record NCT03473743. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 7:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03473743
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
125 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 5, 2018 (Actual)
Primary completion
Sep 30, 2022 (Actual)
Completion
Dec 31, 2026 (Estimated)
Last update posted
Aug 28, 2026

2018 – 2026

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Rocky Mountain Cancer Centers Aurora Colorado 80012 —
Norton Cancer Institute Louisville Kentucky 40202 —
Maryland Oncology Hematology, PA Rockville Maryland 20850 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Weill Cornell Medical College - NY Presbyterian Hospital New York New York 10021 —
White Plains Hospital Center for Cancer Care White Plains New York 10601 —
Levine Cancer Institute, Carolinas HealthCare System Charlotte North Carolina 28204 —
Toledo Clinic Cancer Centers Toledo Ohio 43623-3536 —
Penn State Hershey Cancer Institute Hershey Pennsylvania 17033 —
Texas Oncology, P.A. Fort Worth Texas 76104 —
The University of Texas MD Anderson Cancer Center Houston Texas 77030 —
Virginia Oncology Associates Norfolk Virginia 23502 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 115 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03473743, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 28, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03473743 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →