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.
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)
Women who are pregnant or breastfeeding
Male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy
Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks before the first dose of trial treatment
Has upper tract urothelial carcinoma
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Durvalumab
Biological/VaccineGiven IV
Futibatinib
DrugGiven PO
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Radical Cystectomy
Procedure/SurgeryUndergo radical cystectomy
Complete pathologic response rate
Will be defined by a percentage of participants with ypT0N0 by pathologic responses.
Incidence of adverse events (AEs)
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V 5.0). The frequency and severity of AEs and the tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Pathologic down-staging rate to non-muscle invasive disease
Will be define as residual ypT0/1/a/isN0 on radical cystectomy specimens.
Overall survival
The Kaplan-Meier method will be used for survival analysis with 95% confidence intervals.
Progression free survival
The Kaplan-Meier method will be used for survival analysis with 95% confidence intervals.
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Yuanquan Yang
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Gateway for Cancer Research
Collaborator
