NCT06263153 · Yuanquan Yang
Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy
What this study 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 the usual treatment for patients with MIBC.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Computed Tomography
Undergo CT
BIOLOGICAL
Durvalumab
Given IV
DRUG
Futibatinib
Given PO
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Radical Cystectomy
Undergo radical cystectomy
Primary outcome measures
Complete pathologic response rate
Time frame: 1 day (At the time of radical cystectomy)
Will be defined by a percentage of participants with ypT0N0 by pathologic responses.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Histologically confirmed urothelial carcinoma of the bladder
- Mixed histologies are permitted if urothelial carcinoma is the predominant histology ( \>= 50%)
- 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)
- Refuse or ineligible for cisplatin-based neoadjuvant chemotherapy as defined by any of the following:
- ECOG performance status (PS) \> 1
- Creatinine clearance (calculated or measured) \< 60 mL/min as measured by the Cockcroft-Gault formula
- Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v
Where
- Ann Arbor, Michigan
- Cleveland, Ohio
- Columbus, Ohio
Collaborators
Gateway for Cancer Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 17, 2025 · Source of record for eligibility and locations