Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy

This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal anti

Trial Details

NCT ID
NCT06263153
Phase
PHASE2
Sponsor
Yuanquan Yang
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Durvalumab
  • Futibatinib
  • Magnetic Resonance Imaging
  • Radical Cystectomy
Locations (sample)
  • Ann Arbor, Michigan, United States|42.27756,-83.74088
  • Cleveland, Ohio, United States|41.4995,-81.69541
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Able to provide signed informed consent
  • Female or male subjects \>= 18 years old
  • Bodyweight \>30kg
  • FGFR1, 2, or 3 overexpression as defined by a score of 3+ or 4+ on ribonucleic acid (RNA) in-situ hybridization (RNAScope assay)

For full eligibility, visit ClinicalTrials.gov.

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