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FGFR Inhibitor

Futibatinib + Pembrolizumab for Bladder Cancer

Phase 2
Waitlist Available
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years of age
Unfit for or intolerant to standard platinum-based chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 18 months
Awards & highlights

Study Summary

This trial is testing how well a combination of two drugs works in treating patients with urothelial cancer that has spread and cannot be treated with platinum-based drugs.

Who is the study for?
Adults with advanced or metastatic urothelial carcinoma who can't have platinum-based chemo are eligible. They must be in good physical condition (ECOG PS 0-1), have proper organ function, and measurable disease. Cohort A requires an FGFR3 mutation or FGFR1-4 fusion; Cohort B includes all other patients. Exclusions include significant non-tumor related health issues, recent live vaccines, active autoimmune diseases requiring treatment within 2 years, certain infections like HIV/Hepatitis B/C, prior anti-PD-1/L1/L2 or FGFR inhibitor therapy.Check my eligibility
What is being tested?
The trial is testing the combination of futibatinib (an FGFR inhibitor) and pembrolizumab (a PD-1 antibody) for their effectiveness and safety in treating urothelial cancer when standard chemotherapy isn't suitable.See study design
What are the potential side effects?
Possible side effects may include immune system reactions leading to inflammation in various organs, infusion-related reactions such as fever or chills, fatigue, eye problems due to retinal or corneal disorders considered significant by the doctor overseeing the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I cannot tolerate or am not suitable for standard platinum-based chemotherapy.
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I can carry out all my usual activities without help.
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My cancer has an FGFR3 mutation or an FGFR1-4 fusion.
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My bladder cancer is advanced or has spread, and I haven't had systemic treatment for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Incidence of treatment-emergent Adverse Events (AE)[Safety and Tolerability]
+2 more
Other outcome measures
Estimate area under the plasma concentration-time curve over the dose interval [AUC] of futibatinib at steady-state
Estimate maximum plasma concentration [Cmax] of futibatinib at steady-state
Evaluate the immunomodulatory effects of the combination of futibatinib and pembrolizumab
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: futibatinib and pembrolizumab (Cohort B)Experimental Treatment1 Intervention
All other patients than in Cohort A with UC (including patients with other FGFR or non-FGFR genetic aberrations and patients with wild-type [non-mutated] tumors).
Group II: futibatinib and pembrolizumab (Cohort A)Experimental Treatment1 Intervention
Patients with UC and FGFR3 mutation or FGFR1-4 fusion/rearrangement.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,100 Total Patients Enrolled
Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,538 Total Patients Enrolled

Media Library

Futibatinib (FGFR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04601857 — Phase 2
Bladder Cancer Research Study Groups: futibatinib and pembrolizumab (Cohort A), futibatinib and pembrolizumab (Cohort B)
Bladder Cancer Clinical Trial 2023: Futibatinib Highlights & Side Effects. Trial Name: NCT04601857 — Phase 2
Futibatinib (FGFR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04601857 — Phase 2

Frequently Asked Questions

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

Have Futibatinib and Pembrolizumab achieved official sanction by the FDA?

"The risk assessment for Futibatinib and Pembrolizumab is set at a 2 due to the Phase 2 data, which suggests that there are some safety protocols in place but no efficacy records."

Answered by AI

What diseases can be alleviated by Futibatinib and Pembrolizumab treatments?

"Futibatinib and Pembrolizumab are both capable of managing malignant neoplasms, unresectable melanoma, as well as conditions with high microsatellite instability."

Answered by AI

Are there a plethora of centers in the US conducting this clinical experiment?

"Patient recruitment is occurring at various medical facilities, including the Henry Ford Hospital in Detroit, Michigan; Dana-Farber Cancer Institute in Boston, Massachusetts; and Comprehensive Care Centers of Nevada in Las Vegas."

Answered by AI

What is the ultimate objective of this research endeavor?

"The primary efficacy endpoint of this trial, measured over the timeframe of ~12 months is Objective Response Rate (ORR). Secondary endpoints include Progression-Free Survival (PFS), Duration Of Response (DOR) and Disease Control Rate (DCR) in both Cohorts A and B."

Answered by AI

Could you elaborate on the other experiments that have been conducted featuring Futibatinib and Pembrolizumab?

"In 2010, the City of Hope launched studies on futibatinib and pembrolizumab. Fast-forward to present day and we see 249 completed clinical trials as well as 966 active ones with a majority being conducted in Detroit, Michigan."

Answered by AI

What is the size of the participant pool for this experiment?

"Merck Sharp & Dohme LLC, the sponsoring organization of this trial, needs a total 46 participants with specific inclusion criteria to properly conduct it. The two primary centres for enrolment are located at Henry Ford Hospital in Detroit and Dana-Farber Cancer Institute in Boston."

Answered by AI

Are there any vacancies left in this medical experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, this research is presently searching for participants and was first published on January 21st 2021, with its most recent update being October 25th 2022. The project requires 46 individuals from four distinct sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
2021. "Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04601857.
~0 spots leftby May 2024
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