A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
Bladder Cancer
Unknown Primary
18 Years and older, Male and Female
CR108699 (primary)
NCI-2020-00674
42756493BLC2003
2019-002449-39
Summary
The purpose of this study is to evaluate recurrence-free survival (RFS) in participants
treated with erdafitinib vs Investigator's Choice, for participants with high-risk
non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor
(FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.
Objectives
This study enrolls participants with high risk NMIBC and FGFR mutations or fusions.
Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) 1-4 inhibitor with
demonstrated clinical activity in participants with solid tumors, including urothelial
carcinoma, with alterations in the FGFR pathway. In Cohort 1, participants will be randomized
to erdafitinib or to Investigators Choice (intravesical gemcitabine or intravesical mitomycin
C [MMC] or hyperthermic MMC). The study consists of screening period, treatment phase,
follow-up phase, and long-term extension phase.
Eligibility
- Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed
- Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions
- Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants
- Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only)
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1
- Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- A woman of childbearing potential must have a negative pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) (urine or serum) within 7 days before randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3)
- Adequate bone marrow, liver, and renal function as specified in the protocol
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