A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer
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.
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
Conditions
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 4, 2018
- Primary completion
- Sep 29, 2022
- Completion
- Dec 30, 2026
- Last update posted
- Aug 27, 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 27, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03473743 live on ClinicalTrials.gov.