Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy

Recruiting Phase 2 Interventional Study
Bladder Urothelial Carcinoma Muscle Invasive Bladder Carcinoma Stage II Bladder Cancer AJCC v8 Stage IIIA Bladder Cancer AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Yuanquan Yang · Other
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About This Trial
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,…
Trial Locations
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Eligibility Criteria
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)…
Contacts

The Ohio State Comprehensive Cancer Center

800-293-5066

GUResearchCoordinators@osumc.edu

CONTACT

Rebecca Williams

614-366-0959

Rebecca.Williams3@osumc.edu

CONTACT