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Researchers are evaluating the effects of erdafitinib alone or combined with cetrelimab as a neoadjuvant treatment before surgery for patients with muscle-invasive bladder cancer (MIBC) whose tumors have specific FGFR gene alterations. This study is focused on patients who are either not eligible for or refuse cisplatin-based chemotherapy. The goal is to measure tumor response by checking for complete absence of disease or tumor downstaging after treatment, using pathological assessment of surgical specimens. Participants will be divided into two groups: one receiving erdafitinib alone and the other receiving erdafitinib plus cetrelimab intravenously. These treatments are given before patients undergo radical cystectomy surgery, which will take place within 2 to 6 weeks after the last dose of study drugs. Imaging scans like CT, MRI, or PET will be performed at screening, after treatment, and during follow-up visits to monitor tumor response. During the study, patients will have pathological assessments of their surgical specimens to evaluate treatment effectiveness. Follow-up imaging and pathological exams will continue as clinically appropriate. If disease progresses during treatment, patients will stop the study treatment and be managed according to their doctor's judgment. The main outcomes measured are the rates of complete pathological response and tumor downstaging within 30 weeks from starting treatment.

Age: 18Years +All GendersPhase 2
23 locations
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