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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)


Active: Yes
Cancer Type: Bladder Cancer
Unknown Primary
NCT ID: NCT04172675
Trial Phases: Phase II Protocol IDs: CR108699 (primary)
NCI-2020-00674
42756493BLC2003
2019-002449-39
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Janssen Research & Development, LLC
NCI Full Details: http://clinicaltrials.gov/show/NCT04172675

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
MMC/hyperthermic MMC). The study consists of Screening period, Treatment Phase and Follow-up
Phase.
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