Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Urothelial Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 recept...
Detailed Description
A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
629 Patients enrolled
Trial Details
Trial ID
NCT03390504
Start Date
March 23 2018
End Date
December 31 2026
Last Update
December 22 2025
Active Locations (345)
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1
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States, 99503
2
University of Calif Davis Medical Center
Sacramento, California, United States, 95817
3
St. Helena Hospital - Martin-O'Neil Cancer Center
St. Helena, California, United States, 94574
4
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007