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)
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- STATUS
- Recruiting
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- End date
- Aug 11, 2027
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- participants needed
- 280
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- sponsor
- Janssen Research & Development, LLC
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.
Description
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.
Details
| Condition | Urinary Bladder Neoplasms |
|---|---|
| Treatment | Erdafitinib, Investigator Choice (Gemcitabine), Investigator Choice (Mitomycin C) |
| Clinical Study Identifier | NCT04172675 |
| Sponsor | Janssen Research & Development, LLC |
| Last Modified on | 27 July 2022 |
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