Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
- Conditions
- Advanced and Metastatic Urothelial Cancer
- Interventions
- Registration Number
- NCT04601857
- Lead Sponsor
- Taiho Oncology, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 43
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Willing and able to provide written informed consent for the trial.
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Age ≥ 18 years of age
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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)
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Unfit for or intolerant to standard platinum-based chemotherapy.
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Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
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Adequate organ function.
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Have a measurable disease per RECIST 1.1
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Have received prior therapy with anti-PD-1, anti-PD-L1/L2 agent or FGFR inhibitor.
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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.
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Has received a live vaccine within 30 days prior to the first dose of study drug.
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Have an active autoimmune disease that has required systemic treatment in the past 2 years.
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Have a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
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Have had an allogenic tissue/ organ transplant.
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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.
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Have known active central nervous system metastases and/or carcinomatous meningitis.
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Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
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Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description futibatinib and pembrolizumab (Cohort A) futibatinib and pembrolizumab (KEYTRUDA®)) Patients with UC and FGFR3 mutation or FGFR1-4 fusion/rearrangement. futibatinib and pembrolizumab (Cohort B) futibatinib and pembrolizumab (KEYTRUDA®)) 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).
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Approximately 12 months Objective response rate (ORR), defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR).
- Secondary Outcome Measures
Name Time Method Incidence of treatment-emergent Adverse Events (AE)[Safety and Tolerability] Approximately 8 months Safety and tolerability of the futibatinib and pembolizumab combination therapy based on reported AEs, graded according to the NCI-CTCAE, Version 5.0
Duration of response (DOR) Approximately 8 months DOR defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
Disease control rate (DCR) Approximately 8 months DCR defined as the proportion of patients experiencing a best overall response of stable disease (SD), PR, or CR.
Progression-free survival (PFS) Approximately 8 months PFS defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression, whichever occurs first.
Overall survival (OS) Approximately 18 months OS defined as the time from the date of the first dose to the death date.
Trial Locations
- Locations (18)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Institut Paoli Calmettes - Hôpital de jour
🇫🇷Marseille, Bouches-du-Rhône, France
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Centre Georges-François Leclerc
🇫🇷Dijon, Côte d'Or, France
Centre Regional de Lutte Contre le Cancer de Lorraine
🇫🇷Vandœuvre-lès-Nancy, France
Centre Leon Berard - departement d'oncologie medicale
🇫🇷Lyon, Rhone, France
ALTHAIA, Xarxa Assistencial Universitària de Manresa
🇪🇸Manresa, Brcelona, Spain
Institut De Cancerologie Gustave Roussy
🇫🇷Villejuif, France
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 la Fe
🇪🇸Valencia, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Comprehensive Care Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
ICANS - Institut de cancérologie de Strasbourg Europe
🇫🇷Strasbourg, Bas-Rhin, France
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States