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

  • STATUS
    Recruiting
  • End date
    Sep 13, 2023
  • participants needed
    46
  • sponsor
    Taiho Oncology, Inc.
Updated on 13 June 2021

Summary

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.

Description

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.

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

Eligibility

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note