A Phase 2 Study to Evaluate Erdafitinib Alone or With Cetrelimab as Neoadjuvant Treatment in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer Patients With FGFR Gene Alterations

What this Trial Is About

Researchers are studying erdafitinib alone or combined with cetrelimab as neoadjuvant treatments before surgery in patients with muscle-invasive bladder cancer (MIBC) whose tumors have specific FGFR gene alterations. This trial focuses on patients who cannot receive or choose not to have cisplatin-based chemotherapy. The main goal is to measure tumor response rates based on surgical tissue analysis, including the absence of residual disease and tumor downstaging. Participants are assigned to one of two groups: erdafitinib alone or erdafitinib combined with cetrelimab given intravenously. Both treatments are given before radical cystectomy surgery, which occurs within 2 to 6 weeks after the last dose. Imaging scans such as CT, MRI, or PET are done before treatment, after treatment, and during follow-up to assess tumor status. During the study, patients will have regular imaging and pathological assessments along with safety monitoring. Researchers will track outcomes like pathological complete response, tumor downstaging, event-free survival, overall survival, and any side effects. Participants are followed for up to 36 months to monitor long-term results and surgery timing. Those with disease progression during treatment will stop the study and receive other care as needed.

Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations