RecruitingPhase 2NCT06263153

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


Sponsor

Yuanquan Yang

Enrollment

24 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of futibatinib (a targeted drug blocking FGFR, a protein that drives some bladder cancers) and durvalumab (an immunotherapy) given before bladder removal surgery in people with muscle-invasive bladder cancer who cannot receive standard cisplatin-based chemotherapy. **You may be eligible if...** - You are 18 or older and weigh more than 30 kg - You have confirmed urothelial carcinoma of the bladder at Stage T2–T4a (muscle-invasive, no spread to lymph nodes or distant sites) - Your tumor has a specific protein change (FGFR overexpression) detected by a lab test - You cannot receive cisplatin-based chemotherapy due to kidney function, hearing loss, nerve damage, or heart function - You are otherwise fit for and planning to have your bladder surgically removed - You are in reasonably good health (ECOG score 0, 1, or 2) **You may NOT be eligible if...** - You do not have FGFR overexpression - You have cancer that has spread beyond the bladder and nearby lymph nodes - You received prior anti-PD-1/PD-L1 therapy less than 3 months ago - You are pregnant or breastfeeding - You have significant heart, eye, or bone problems related to FGFR inhibitor side effects Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

BIOLOGICALDurvalumab

Given IV

DRUGFutibatinib

Given PO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDURERadical Cystectomy

Undergo radical cystectomy


Locations(3)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06263153


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