Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma

  • End date
    Sep 13, 2023
  • participants needed
  • sponsor
    Taiho Oncology, Inc.
Updated on 13 June 2021


The purpose of the trial is to evaluate a response to combination of Fibroblast Growth Factor Receptor (FGFR) inhibitor futibatinib and anti-programmed cell death-1 (PD-1) antibody pembrolizumab in patients with advanced or spreading urothelial cancer who are not candidates to receive a platinum-based treatment regimens. It also will help us to learn about the side effects of this combination therapy. This study will also help us to find the futibatinib and pembrolizumab predictive markers of response (i.e. benefit from specific treatment; helps to select particular treatment over another). Another objective is to evaluate the supposed futibatinib and pembrolizumab combination's immunomodulatory effects (i.e. Drug that modifies the immune response or the functioning of the immune system as by the stimulation of antibody formation or the inhibition of white blood cell activity). By conducting this study, we will learn about the variability in drug concentrations within a patient population receiving clinically relevant doses of a futibatinib and pembrolizumab. Pharmacokinetics allows us to examine how the body processes a drug.


This study is an open-label, nonrandomized, multicenter Phase 2 study evaluating the combination of futibatinib and pembrolizumab in patients with advanced or metastatic UC who are not candidates to receive a platinum-based treatment regimen.

Approximately 46 subjects advanced or metastatic Urothelial Cancer (UC) will be enrolled in the trial at approximately 15-17 sites worldwide:

  • 6 patients in the safety lead-in
  • 20 patients with tumors characterized by specific genetic abnormalities (Cohort A)
  • 20 patients with tumors not characterized by specific genetic abnormalities (Cohort B).

A treatment cycle is defined as 21 days. All enrolled participants will receive the same treatment

  • Futibatinib at an oral (PO) dose of 20 mg daily (5 tablets) (QD); and
  • Pembrolizumab at an intravenous (I.V.) dose of 200 mg every 3 weeks (Q3W).

Treatment will continue until disease progression, unacceptable side effects, or any other of the criteria for treatment discontinuation is met; of note, pembrolizumab may be administered for a maximum of 35 doses or a maximum duration of 2 years, whichever is earlier. The study will begin with a safety lead-in period. During this period, a total of 6 patients with advanced or metastatic urothelial carcinoma will be enrolled and treated for at least one 21-day cycle. Patients will be enrolled into this initial safety lead-in period without regard for FGFR alteration status.

Condition Advanced and Metastatic Urothelial Cancer
Treatment Futibatinib and Pembrolizumab
Clinical Study IdentifierNCT04601857
SponsorTaiho Oncology, Inc.
Last Modified on13 June 2021


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