Schéma : This open-label (all people know identity of intervention) and multicenter (when more than one hospital or medical school team work on a medical research study) study of erdafitinib plus cetrelimab in participants with advanced urothelial cancer with selected fibroblast growth factor receptor (FGFR) gene alterations, will consists of 2 parts. Participants enrolled in Part 1 may have received any number of lines of prior therapy, and participants enrolled in Part 2 will have had no prior systemic therapy for metastatic disease and cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will establish recommended Phase 2 dose (RP2D) for erdafitinib in combination with cetrelimab, and Part 2 (Phase 2: Dose Expansion) will evaluate safety and efficacy of RP2D. The study will be conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and safety.
Phase : I/II
Stade : Localement avancé à Métastasique
1, 2, 3, 4, X