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
Official title: A Phase II Trial of Futibatinib in Combination With Durvalumab (MEDI4736) Administered to Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer Before Cystectomy
Is NCT06263153 recruiting? Yes, currently enrolling (Oct 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
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: FGFR1 overexpression (score of 3+ or 4+ on RNA in-situ hybridization (RNAScope assay))
FGFR1, 2, or 3 overexpression as defined by a score of 3+ or 4+ on ribonucleic acid (RNA) in-situ hybridization (RNAScope assay)
Required: FGFR2 overexpression (score of 3+ or 4+ on RNA in-situ hybridization (RNAScope assay))
FGFR1, 2, or 3 overexpression as defined by a score of 3+ or 4+ on ribonucleic acid (RNA) in-situ hybridization (RNAScope assay)
Required: FGFR3 overexpression (score of 3+ or 4+ on RNA in-situ hybridization (RNAScope assay))
FGFR1, 2, or 3 overexpression as defined by a score of 3+ or 4+ on ribonucleic acid (RNA) in-situ hybridization (RNAScope assay)
Disease stage
Required: Stage STAGE II, STAGE IIIA (other)
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 for muscle-invasive bladder cancer
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 for MIBC
Exception: except 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
Cannot have received: FGFR inhibitor for MIBC
Exception: except 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 per mm^3; Platelet count ≥ 100 x 10^9/L; INR or aPTT < 1.5 × ULN unless on anticoagulation and within therapeutic range
Kidney function
Measured creatinine clearance (CL) ≥ 30 mL/min or calculated creatinine CL ≥ 30 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Liver function
Bilirubin ≤ 1.5 x institutional ULN; AST/ALT ≤ 2.5 x institutional ULN
Cardiac function
NYHA class > II cardiac dysfunction ineligible; Myocardial infarction or unstable angina pectoris within 3 months of first date of study therapy; Unstable arrhythmias; Decompensated heart failure; Uncontrolled hypertension and unstable angina pectoris; Average QTcF > 470 msec (males and females)
Bilirubin ≤ 1.5 x institutional ULN; AST/ALT ≤ 2.5 x institutional ULN; Measured creatinine clearance (CL) ≥ 30 mL/min or calculated creatinine CL ≥ 30 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance; 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; NYHA class > II cardiac dysfunction ineligible; Myocardial infarction or unstable angina pectoris within 3 months of first date of study therapy; Unstable arrhythmias; Decompensated heart failure; Uncontrolled hypertension and unstable angina pectoris; Average QTcF > 470 msec (males and females)
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 →Frequently asked questions
Is NCT06263153 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic chemotherapy for muscle-invasive bladder cancer, anti-PD-1/PD-L1 therapy for MIBC, FGFR inhibitor for MIBC disqualifies patients from enrollment.
Does this trial require FGFR1?
Yes, FGFR1 overexpression is a required biomarker for enrollment.
Does this trial require FGFR2?
Yes, FGFR2 overexpression is a required biomarker for enrollment.
Does this trial require FGFR3?
Yes, FGFR3 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage STAGE II or STAGE IIIA is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages