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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYuanquan Yang

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, 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 criteria

Qualifiers

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)

Disqualifiers

Women who are pregnant or breastfeeding

Male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy

Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks before the first dose of trial treatment

Has upper tract urothelial carcinoma

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Durvalumab
  • Futibatinib
  • Magnetic Resonance Imaging
  • Radical Cystectomy

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators

Yuanquan Yang

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Gateway for Cancer Research

Collaborator