At a glance
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A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer
In Brief
A Phase 2 clinical trial evaluating Erdafitinib, Cetrelimab, and 2 other interventions for Urothelial Carcinoma. Active but no longer recruiting, targeting 125 participants across 127 sites in 13 countries.
Detailed Summary
The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.
Study Details
Timeline
Interventions
Participants will receive erdafitinib orally.
Participants will receive cetrelimab by intravenous infusion.
Participants will receive cisplatin by intravenous infusion as a part of platinum chemotherapy.
Participants will receive carboplatin by intravenous infusion as a part of platinum chemotherapy.