drugset / Trial / NCT06511648
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Phase 2
Recruiting
90 enrolled
Spanish Oncology Genito-Urinary Group
Janssen-Cilag Ltd. · collabPivotal S.L. · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express Fibroblast Growth Factor Receptor (FGFR )gene alterations and are ineligible for or refuse cisplatin based neoadjuvant chemotherapy.
Timeline
- Start
- 2023-03-07
- Primary completion
- 2026-07
- Completion
- 2029-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetrelimab | Monoclonal antibody | — | Intravenous |
| Subject | Erdafitinib | Small molecule | — | Intravenous |