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Clinical Trials in the UK / NCT03390504
Active, not recruiting Phase 3

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 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2018-03-23
Last updated
2026-07-06

Condition(s) studied

Urothelial Cancer

Investigational drug(s) / intervention(s)

ErdafitinibVinflunineDocetaxelPembrolizumabFibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)

Erdafitinib: Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.

Vinflunine: Participants will receive vinflunine 320 mg/m\^2 as a 20-minute intravenous infusion.

Docetaxel: Participants will receive docetaxel 75 mg/m\^2 as a 1 hour intravenous infusion.

Pembrolizumab: Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.

Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA): FGFRi CTA will be used to determine molecular eligibility.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than \[\<\] 50 percent \[%\] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable * Metastatic or surgically unresectable urothelial cancer * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting. * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin \[beta hCG\]) at Screening (urine or serum) * Participants must meet appropriate molecular eligibility criteria * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 * Adequate bone marrow, liver, and renal function Exclusion Criteria: * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence. * Symptomatic central nervous system metastases * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade. * History of uncontrolled cardiovascular disease * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions

Primary outcome measure(s)

Trial sites (345)

FacilityCityRegionStatus
Alaska Urological Institute dba Alaska Clinical Research Center Anchorage Alaska
University of Calif Davis Medical Center Sacramento California
St. Helena Hospital - Martin-O'Neil Cancer Center St. Helena California
MedStar Georgetown University Hospital Washington D.C. District of Columbia
University of Miami Sylvester Cancer Center Miami Florida
Mid Florida Hematology Oncology Orange Florida
Piedmont Cancer Institute Atlanta Georgia
Rush University Chicago Illinois
Edward Hines Jr V A Hospital Hines Illinois
Norton Cancer Institute Louisville Kentucky
Maryland Oncology Hematology, PA Lanham Maryland
University of Michigan Health System Ann Arbor Michigan
VA Sierra Nevada Health Care System Reno Nevada
Dartmouth Hitchcock Medical Center Lebanon New Hampshire
Weill Cornell Medical College New York New York
Montefiore Medical Center The Bronx New York
Levine Cancer Institute, Carolinas HealthCare System Charlotte North Carolina
W G Bill Hefner VA Medical Center Salisbury North Carolina
Oncology Hematology Care Cincinnati Ohio
The Center for Cancer and Blood Disorders Fort Worth Texas
Texas Oncology-Memorial City Houston Texas
MD Anderson Cancer Center Houston Texas
Texas Oncology Tyler Tyler Texas
INOVA Dwiight &Martha Schar Cancer Institute Fairfax Virginia
Virginia Oncology Associates Norfolk Virginia
VA Puget Sound Healthcare System Seattle Washington
Sociedade Beneficente de Senhoras Hospital Sirio Libanes Buenos Aires Argentina
Centro Oncológico Korben Buenos Aires Argentina
CEMIC Saavedra Buenos Aires Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Córdoba Argentina
Centro Urologico Profesor Bengio Córdoba Argentina
Hospital Privado de Comunidad Mar del Plata Argentina
Centro de Investigacion Pergamino SA Pergamino Argentina
Clínica Viedma Viedma Argentina
Chris O'Brien Lifehouse Camperdown Australia
Peninsula & South Eastern Haematology and Oncology Group Frankston Australia
St George Hospital Kogarah Australia
Peter MacCallum Cancer Centre Melbourne Australia
Frankston Hospital Melbourne Australia
Fiona Stanley Hospital Murdoch Australia

+ 305 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03390504 on ClinicalTrials.gov ↗ ← All trials in the UK