← Back to Search

Tyrosine Kinase Inhibitor

Treatment (futibatinib, durvalumab, radical cystectomy) for Bladder Cancer

Phase 2

Waitlist Available

Led By Yuanquan Yang, MD, PhD

Research Sponsored by Yuanquan Yang

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed urothelial carcinoma of the bladder

Clinical stage T2-T4a, N0, M0 disease by trans urethral removal of bladder tumour (TURBT) and imaging studies (stage II-IIIA per American Joint Committee on Cancer [AJCC] 2018)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from the start date of treatment to death on the study from any cause, assessed up to 2 years

Awards & highlights

Study Summary

This trial is testing a combination of two drugs, futibatinib and durvalumab, given before surgery to treat patients with muscle-invasive bladder cancer who cannot have the standard treatment with cis

Who is the study for?

This trial is for muscle-invasive bladder cancer patients who can't have the standard cisplatin-based therapy due to issues like poor kidney function, nerve damage, weak physical condition, or serious heart failure. Participants will undergo surgery to remove the bladder and should not have had prior treatments that would affect their eligibility.Check my eligibility

What is being tested?

The study tests a combination of two drugs, futibatinib and durvalumab, given before bladder removal surgery (radical cystectomy). Futibatinib blocks enzymes needed for tumor growth while durvalumab targets tumor cells' ability to spread. The aim is to see if this drug combo works well as an alternative treatment.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs (like inflammation), infusion reactions from receiving drugs through a vein, fatigue, nausea or diarrhea. There may also be risks associated with undergoing major surgery such as bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My bladder cancer has been confirmed by a tissue examination.

Select...

My bladder cancer is at a stage where it's grown but not spread to lymph nodes or distant organs.

Select...

I cannot have cisplatin-based chemotherapy due to my health condition.

Select...

My cancer shows high FGFR1, 2, or 3 levels on a specific test.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the start date of treatment to death on the study from any cause, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the start date of treatment to death on the study from any cause, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the start date of treatment to death on the study from any cause, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete pathologic response rate

Secondary outcome measures

Frequency and severity of adverse events, including delay in cystectomy

Incidence of adverse events (AEs)

Overall survival

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (futibatinib, durvalumab, radical cystectomy)Experimental Treatment6 Interventions

Patients receive futibatinib PO QD on days 1-28 and durvalumab 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 CT and MRI during screening and on the trial and also undergo blood sample collection on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radical Cystectomy

2006

Completed Phase 2

~140

Futibatinib

2014

Completed Phase 2

~410

Biospecimen Collection

2004

Completed Phase 2

~1700

Durvalumab

2017

Completed Phase 2

~3870

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gateway for Cancer ResearchOTHER

45 Previous Clinical Trials

2,539 Total Patients Enrolled

Yuanquan YangLead Sponsor

Yuanquan Yang, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to enroll in this clinical trial?

"As per the details on clinicaltrials.gov, recruitment for this particular trial is presently closed. The initial posting was made on March 1st, 2024, with the latest update occurring on February 15th of the same year. While this study is not actively seeking participants currently, there are a total of 2776 other trials that are open and recruiting patients at present."

Answered by AI

What are the risks associated with receiving futibatinib, durvalumab, and undergoing radical cystectomy as a treatment regimen?

"The safety evaluation for the treatment regimen (futibatinib, durvalumab, radical cystectomy) is rated at 2 by our team at Power on a scale from 1 to 3. This rating reflects that although there is some existing safety data available, no evidence currently supports its efficacy in this Phase 2 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Yuanquan Yang 2024. "Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06263153.