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

A Phase II Trial of Futibatinib in Combination With Durvalumab (MEDI4736) Administered to Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer Before Cystectomy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Yuanquan Yang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. Determine the pathologic complete response(pCR) rate of neoadjuvant combination futibatinib and durvalumab in patients with MIBC and fibroblast growth factor receptor (FGFR) overexpression. SECONDARY OBJECTIVES: I. Determine the safety of this neoadjuvant regimen. II. Assess the pathologic downstaging rate. III. Evaluate overall survival (OS) and progression free survival (PFS). IV. Evaluate delay in cystectomy. EXPLORATORY OBJECTIVES: I. Evaluate potential predictive biomarkers. II. Assess changes in the tumor microenvironment in pre- and post-treatment tumor samples in participants. OUTLINE: Patients receive futibatinib orally (PO) once daily (QD) on days 1-28 and durvalumab intravenously (IV) over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo radical cystectomy within 4-12 weeks. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) during screening and on the trial and also undergo blood sample collection on the trial. After completion of study treatment, patients are followed up at 30 days, and then every 3 months for 2 years.

Conditions

• Bladder Urothelial Carcinoma
• Muscle Invasive Bladder Carcinoma
• Stage II Bladder Cancer AJCC v8
• Stage IIIA Bladder Cancer AJCC v8

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-02-16
• Last updated: 2025-12-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study