Study on Futibatinib and Durvalumab Before Bladder Removal Surgery for Muscle-Invasive Bladder Cancer Patients Who Can't Use Cisplatin Therapy

Sponsor: Yuanquan Yang

Sponsor score: 0

ClinicalTrials ID:NCT06263153

Provider View

This clinical trial is exploring a new treatment option for patients with muscle-invasive bladder cancer who cannot undergo standard cisplatin-based therapy. The study tests the effectiveness of combining two drugs, futibatinib and durvalumab, before bladder removal surgery.

Patient Parameters

Program Overview

The purpose of this study is to see if using the drugs futibatinib and durvalumab before bladder removal surgery can help treat muscle-invasive bladder cancer in patients who cannot receive the usual cisplatin-based therapy. Futibatinib may help stop cancer cells from growing, while durvalumab may help prevent cancer cells from spreading. The study aims to find out if this combination can be a good treatment option for these patients.

Description

The main goal of this study is to find out how well the combination of futibatinib and durvalumab works in completely eliminating cancer in patients with muscle-invasive bladder cancer who have high levels of a protein called FGFR.

Other goals include checking the safety of this treatment, seeing how much the cancer shrinks, and evaluating how long patients live without the cancer getting worse. The study will also look at any delays in surgery and explore changes in the cancer environment before and after treatment.

Participants will take futibatinib by mouth every day and receive durvalumab through an IV once every 28 days for up to three cycles, as long as the cancer does not progress or cause severe side effects. After the treatment, patients will have bladder removal surgery within 4 to 12 weeks. They will also have CT and MRI scans and provide blood samples during the study.

After finishing the study treatment, patients will have follow-up visits 30 days later and then every three months for two years.

Eligibility Criteria

Inclusion Criteria

  • Able to provide signed informed consent
  • Age 18 years or older
  • Weigh more than 30 kg
  • High levels of FGFR1, 2, or 3 proteins in cancer cells
  • Good overall health with an ECOG performance status of 0, 1, or 2
  • Diagnosed with bladder cancer, mainly urothelial carcinoma
  • Cancer stage T2-T4a, N0, M0 based on tests
  • Cannot or choose not to have cisplatin-based chemotherapy due to health reasons
  • Eligible for bladder removal surgery
  • Provide a tumor sample from a previous procedure
  • Women must not be pregnant and must use effective birth control
  • Men must agree to use effective birth control
  • Meet specific blood and organ function requirements
  • Willing to follow the study protocol and attend all visits
  • Expected to live at least 12 more weeks

Exclusion Criteria

  • Women who are pregnant or breastfeeding
  • Not willing to use birth control during the study
  • Participating in another study or using an investigational device recently
  • Have upper tract urothelial carcinoma or small-cell carcinoma
  • Have cancer that has spread to other parts of the body
  • Receiving other cancer treatments
  • Previously treated with certain cancer therapies
  • Have active heart disease or other serious health conditions
  • Have autoimmune or inflammatory disorders
  • Have active infections like HIV, hepatitis B, or hepatitis C
  • Have a history of organ transplantation
  • Have allergies to study drugs
  • Recently received a live vaccine
  • Have unresolved side effects from previous cancer treatments

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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