OncoMatch/Clinical Trials/NCT06263153
Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy
Is NCT06263153 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Durvalumab and Futibatinib for bladder urothelial carcinoma.
Treatment: Durvalumab · Futibatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: FGFR1 overexpression (3+ or 4+ on rna in-situ hybridization (rnascope assay))
Required: FGFR2 overexpression (3+ or 4+ on rna in-situ hybridization (rnascope assay))
Required: FGFR3 overexpression (3+ or 4+ on rna in-situ hybridization (rnascope assay))
Disease stage
Required: Stage II, IIIA (AJCC v8)
Clinical stage T2-T4a, N0, M0 disease by trans urethral removal of bladder tumour (TURBT) and imaging studies (stage II-IIIA per American Joint Committee on Cancer [AJCC] 2018)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic chemotherapy
Exception: prior systemic chemotherapy for muscle-invasive bladder cancer at any time in the patient's medical history
Received prior systemic chemotherapy for muscle-invasive bladder cancer at any time in the patient's medical history
Cannot have received: anti-PD-1/PD-L1 therapy
Exception: permitted if used in earlier stage urothelial carcinoma such as non-muscle invasive bladder cancer (NMIBC) and completed > 3 months prior to registration, with additional safety criteria
Has received anti-PD-1/PD-L1 therapy or FGFR inhibitor previously for MIBC, except if used in earlier stage urothelial carcinoma such as non-muscle invasive bladder cancer (NMIBC) and completed > 3 months prior to registration
Cannot have received: FGFR inhibitor
Exception: permitted if used in earlier stage urothelial carcinoma such as non-muscle invasive bladder cancer (NMIBC) and completed > 3 months prior to registration
Has received anti-PD-1/PD-L1 therapy or FGFR inhibitor previously for MIBC, except if used in earlier stage urothelial carcinoma such as non-muscle invasive bladder cancer (NMIBC) and completed > 3 months prior to registration
Lab requirements
Blood counts
Hemoglobin >= 9.0 g/dL; ANC > 1500/mm^3; Platelet count >= 100 x 10^9/L; INR or aPTT < 1.5 × ULN unless on anticoagulation and within therapeutic range
Kidney function
Creatinine clearance > 30 mL/min (measured or calculated by Cockcroft-Gault or 24-hour urine collection)
Liver function
Serum bilirubin <= 1.5 x institutional ULN; AST/ALT <= 2.5 x institutional ULN
Cardiac function
NYHA class > II cardiac dysfunction ineligible; QTcF > 470 msec ineligible unless average of 3 ECGs <= 470 msec
Hemoglobin >= 9.0 g/dL; ANC > 1500 per mm^3; Platelet count >= 100 x 10^9/L; INR or aPTT < 1.5 × ULN unless on anticoagulation and within therapeutic range; Serum bilirubin <= 1.5 x institutional ULN; AST/ALT <= 2.5 x institutional ULN; Phosphorus ≤ institutional ULN; Creatinine clearance > 30 mL/min (measured or calculated by Cockcroft-Gault or 24-hour urine collection); NYHA class > II cardiac dysfunction ineligible; QTcF > 470 msec ineligible unless average of 3 ECGs <= 470 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Michigan Comprehensive Cancer Center · Ann Arbor, Michigan
- Cleveland Clinic Taussig Cancer Center · Cleveland, Ohio
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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