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

Stopped early · Phase 2

Conditions studied: Advanced and Metastatic Urothelial Cancer

In brief

The purpose of the trial is to evaluate the antitumor activity and confirm the safety for the combination of Fibroblast Growth Factor Receptor (FGFR) inhibitor futibatinib and anti-programmed cell death-1 (PD-1) antibody pembrolizumab in patients with advanced or metastatic urothelial cancer who are not candidates to receive a platinum-based treatment regimens.

Key facts

Study ID: NCT04601857
Run by: Taiho Oncology, Inc.
People needed: 43
Starts: 2021-01-07
Expected to finish: 2025-09-16
Last updated by the study team: 2025-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Willing and able to provide written informed consent for the trial.
Age ≥ 18 years of age
Histologically confirmed advanced or metastatic urothelial carcinoma who have not received systemic treatment for advanced metastatic disease.
Cohort A: must have an FGFR3 mutation or FGFR1-4 fusion/rearrangement.
Cohort B: all other patients with UC (including patients with other FGFR or non-FGFR genetic aberrations and patients with wild-type [non-mutated] tumors)
Unfit for or intolerant to standard platinum-based chemotherapy.
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
Adequate organ function.
Have a measurable disease per RECIST 1.1

You may not qualify if…

Have received prior therapy with anti-PD-1, anti-PD-L1/L2 agent or FGFR inhibitor.
History and/or current evidence of any of the following disorders:
Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator.
Ectopic mineralization/calcification considered clinically significant in the opinion of the Investigator.
Retinal or corneal disorder considered clinically significant in the opinion of the Investigator.
Has received a live vaccine within 30 days prior to the first dose of study drug.
Have an active autoimmune disease that has required systemic treatment in the past 2 years.
Have a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
Have had an allogenic tissue/ organ transplant.
Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA.
Have known active central nervous system metastases and/or carcinomatous meningitis.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.

Where it is running

UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Henry Ford Hospital — Detroit, Michigan, United States
Comprehensive Care Centers of Nevada — Las Vegas, Nevada, United States
ICANS - Institut de cancérologie de Strasbourg Europe — Strasbourg, Bas-Rhin, France
Institut Paoli Calmettes - HÃ´pital de jour — Marseille, Bouches-du-Rhône, France
Centre Georges-François Leclerc — Dijon, Côte d'Or, France
Centre Leon Berard - departement d'oncologie medicale — Lyon, Rhone, France
Centre Regional de Lutte Contre le Cancer de Lorraine — Vandœuvre-lès-Nancy, France
Institut De Cancerologie Gustave Roussy — Villejuif, France
ALTHAIA, Xarxa Assistencial Universitària de Manresa — Manresa, Brcelona, Spain
Hospital Clinic de Barcelona — Barcelona, Spain
Hospital de La Santa Creu i Sant Pau — Barcelona, Spain
Hospital Universitario Vall d'Hebrón — Barcelona, Spain
Hospital Universitario Reina Sofia — Córdoba, Spain
Hospital Universitario HMN Sanchinarro — Madrid, Spain
Hospital Universitario Marqués de Valdecilla — Santander, Spain
Hospital la Fe — Valencia, Spain

Full record on ClinicalTrials.gov

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