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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Yuanquan Yang
Study ID
NCT06263153
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Bladder Urothelial Carcinoma
  • Muscle Invasive Bladder Carcinoma
  • Stage II Bladder Cancer AJCC v8
  • Stage IIIA Bladder Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Durvalumab — BIOLOGICAL
    Given IV
  • Futibatinib — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Radical Cystectomy — PROCEDURE
    Undergo radical cystectomy

Study Details

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.

Key Dates

Start date
Dec 30, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (futibatinib, durvalumab, radical cystectomy)
    Patients receive futibatinib PO QD on days 1-28 and durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo radical cystectomy within 4-12 weeks. Patients also undergo CT and MRI during screening and on the trial and also undergo blood sample collection on the trial.

Primary Outcome Measure

Complete pathologic response rate [ Time Frame: 1 day (At the time of radical cystectomy) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195
Shilpa Gupta, MD
[email protected]
216-444-6833
Shilpa Gupta, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Yuanquan Yang, MD, PhD
[email protected]
614-366-2485
Yuanquan Yang, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MICleveland Clinic Taussig Cancer Center· Cleveland, OHOhio State University Comprehensive Cancer Center· Columbus, OH

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