protocolSection identificationModule nctId: NCT06263153, orgStudyIdInfo id: OSU-23329, secondaryIdInfos id: NCI-2024-00002, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), briefTitle: Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Yuanquan Yang, class: OTHER, collaborators name: Gateway for Cancer Research, descriptionModule briefSummary: 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., conditionsModule conditions: Bladder Urothelial Carcinoma, conditions: Muscle Invasive Bladder Carcinoma, conditions: Stage II Bladder Cancer AJCC v8, conditions: Stage IIIA Bladder Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Durvalumab, interventions name: Futibatinib, interventions name: Magnetic Resonance Imaging, interventions name: Radical Cystectomy, outcomesModule primaryOutcomes measure: Complete pathologic response rate, secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Pathologic down-staging rate to non-muscle invasive disease, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Frequency and severity of adverse events, including delay in cystectomy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Yuanquan Yang, MD, PhD, role: CONTACT, phone: 614-366-2485, email: Yuanquan.Yang@osumc.edu, contacts name: Yuanquan Yang, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False