Actively Recruiting
Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy
Led by Yuanquan Yang · Updated on 2025-12-17
24
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
Y
Yuanquan Yang
Lead Sponsor
G
Gateway for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent
- Male or female subjects 18 years or older
- Bodyweight greater than 30 kg
- FGFR1, 2, or 3 overexpression confirmed by RNA in-situ hybridization assay
- ECOG performance status of 0, 1, or 2
- Histologically confirmed urothelial carcinoma of the bladder with at least 50% urothelial histology if mixed
- Clinical stage T2-T4a, N0, M0 disease (stage II-IIIA per AJCC 2018)
- Refuse or are ineligible for cisplatin-based chemotherapy due to any: ECOG >1, creatinine clearance <60 mL/min, grade ≥2 hearing loss, grade ≥2 neuropathy, or NYHA class > II cardiac dysfunction
- Completed anti-PD-1/PD-L1 therapy for non-muscle invasive bladder cancer more than 3 months before registration
- Eligible and planned for radical cystectomy per local guidelines
- Archival or biopsy tumor tissue available with at least 20% viable tumor
- Post-menopausal status or negative pregnancy test for premenopausal females
- Agree to use effective contraception during study and 90 days after last dose
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count > 1500/mm3
- Platelet count ≥ 100 x 10^9/L
- INR or aPTT <1.5 x upper limit of normal unless on anticoagulation within therapeutic range
- Serum bilirubin ≤ 1.5 x upper limit of normal
- AST/ALT ≤ 2.5 x upper limit of normal
- Phosphorus ≤ institutional upper limit of normal
- Creatinine clearance > 30 mL/min by Cockcroft-Gault or 24-hour urine
- Willing and able to comply with study procedures and follow-up
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients unwilling to use effective birth control from screening to 90 days after last durvalumab dose
- Participation in another investigational drug or device study within 4 weeks before treatment
- Presence of upper tract urothelial carcinoma
- Small-cell carcinoma component on tumor histology
- Measurable nodal or metastatic disease
- Receiving concurrent anticancer therapy
- Prior systemic chemotherapy for muscle-invasive bladder cancer
- Previous anti-PD-1/PD-L1 or FGFR inhibitor therapy for muscle-invasive bladder cancer, except completed anti-PD-1/PD-L1 for NMIBC >3 months prior with resolved toxicities
- Recent major surgery without adequate recovery
- Active second malignancy except low-risk localized prostate cancer on watch and wait
- Active cardiac disease including recent myocardial infarction, unstable angina, arrhythmias, decompensated heart failure, uncontrolled hypertension, or QTcF >470 msec
- Medical conditions preventing radical cystectomy
- Use of high-dose systemic corticosteroids within 2 weeks
- Active or prior autoimmune or inflammatory disorders except certain stable conditions
- HIV with detectable viral load or low CD4 count, or active tuberculosis
- Active hepatitis B or C infection
- Significant ectopic mineralization or corneal/retinal disorders
- Endocrine disorders affecting calcium/phosphate unless well controlled
- Use of strong CYP3A or P-glycoprotein drugs within 7 days before treatment
- Other medical or psychiatric conditions interfering with study
- Allergy to study drugs or excipients
- Live attenuated vaccine within 30 days before first dose
- Uncontrolled illnesses, infections, or serious gastrointestinal conditions with diarrhea
- Unresolved grade ≥2 toxicity from prior cancer therapy except alopecia, vitiligo, and specified labs
- History of allogenic organ transplantation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Withdrawn
2
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
3
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State Comprehensive Cancer Center
CONTACT
R
Rebecca Williams
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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