A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants Wit… (NCT03390504) | Clinical Trial Compass
Active — Not RecruitingPhase 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
United States629 participantsStarted 2018-03-23
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 random…
What they're measuring
1
Overall Survival (OS)
Timeframe: From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months)