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

Running, not enrolling · Phase 3

Conditions studied: Urothelial Cancer

In brief

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).

Key facts

Study ID

NCT03390504

Run by

Janssen Research & Development, LLC

People needed

629

Starts

2018-03-23

Expected to finish

2026-12-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Calif Davis Medical Center — Sacramento, California, United States
• St. Helena Hospital - Martin-O'Neil Cancer Center — St. Helena, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Miami Sylvester Cancer Center — Miami, Florida, United States
• Mid Florida Hematology Oncology — Orange, Florida, United States
• Piedmont Cancer Institute — Atlanta, Georgia, United States
• Rush University — Chicago, Illinois, United States
• Edward Hines Jr V A Hospital — Hines, Illinois, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Maryland Oncology Hematology, PA — Lanham, Maryland, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• VA Sierra Nevada Health Care System — Reno, Nevada, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Weill Cornell Medical College — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Levine Cancer Institute, Carolinas HealthCare System — Charlotte, North Carolina, United States
• W G Bill Hefner VA Medical Center — Salisbury, North Carolina, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• The Center for Cancer and Blood Disorders — Fort Worth, Texas, United States
• Texas Oncology-Memorial City — Houston, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Texas Oncology Tyler — Tyler, Texas, United States
• INOVA Dwiight &Martha Schar Cancer Institute — Fairfax, Virginia, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Alaska Urological Institute dba Alaska Clinical Research Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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