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

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later Dec 31, 2026 → Jul 31, 2027
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Record History

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  1. Notable Primary and study completion pushed from Dec 31, 2026 to Jul 31, 2027
    • Eligibility criteria expanded, about 51 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. Minor Site details revised at 1 of 3 sitesv9
  3. Minor Study sites: 2 to 3v8
  4. Minor Study sites: 1 to 2v7
  5. Notable Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
    • Start date changed from estimate of Nov 1, 2024 to Dec 30, 2024
    • Study description revised
    • Site contact updated
    v6
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  1. Notable Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Start date: Aug 1, 2024 to Nov 1, 2024
    • Eligibility criteria expanded, about 257 words
    • Study description revised
    • Site details revised
  2. Notable Start date: Jun 1, 2024 to Aug 1, 2024v4
  3. Notable Start date: Apr 1, 2024 to Jun 1, 2024v3
  4. Notable Start date: Mar 1, 2024 to Apr 1, 2024
    • Secondary endpoints: details revised at 1 of 5 entries
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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 antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy.
Trial Details
NCT Number NCT06263153
Lead Sponsor Yuanquan Yang
Collaborators: Gateway for Cancer Research
Conditions
(from sponsor)
Bladder Urothelial Carcinoma, Muscle Invasive Bladder Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8
Related terms Urinary Bladder Neoplasms
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov