Back to resultsFutibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
Primary Purpose
Advanced and Metastatic Urothelial Cancer
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
futibatinib and pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Advanced and Metastatic Urothelial Cancer focused on measuring Futibatinib, Pembrolizumab, Urothelial cancer, FGFR, TAS120, MK3475 B04
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer CenterRecruiting
- Dana Farber Cancer Institute
- Henry Ford HospitalRecruiting
- Comprehensive Care Centers of NevadaRecruiting
- ICANS - Institut de cancérologie de Strasbourg EuropeRecruiting
- Institut Paoli Calmettes - Hôpital de jourRecruiting
- Centre Georges-François LeclercRecruiting
- Centre Leon Berard - departement d'oncologie medicaleRecruiting
- Centre Regional de Lutte Contre le Cancer de LorraineRecruiting
- Institut De Cancerologie Gustave RoussyRecruiting
- ALTHAIA, Xarxa Assistencial Universitària de ManresaRecruiting
- Hospital Clinic de BarcelonaRecruiting
- Hospital de La Santa Creu i Sant PauRecruiting
- Hospital Universitario Vall d'HebrónRecruiting
- Hospital Universitario Reina SofiaRecruiting
- Hospital Universitario HMN SanchinarroRecruiting
- Hospital Universitario Marqués de ValdecillaRecruiting
- Hospital la FeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
futibatinib and pembrolizumab (Cohort A)
futibatinib and pembrolizumab (Cohort B)
Arm Description
Patients with UC and FGFR3 mutation or FGFR1-4 fusion/rearrangement.
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).
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
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
Disease control rate (DCR)
DCR defined as the proportion of patients experiencing a best overall response of stable disease (SD), PR, or CR.
Duration of response (DOR)
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.
Progression-free survival (PFS)
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)
OS defined as the time from the date of the first dose to the death date.
Incidence of treatment-emergent Adverse Events (AE)[Safety and Tolerability]
Safety and tolerability of the futibatinib and pembolizumab combination therapy based on reported AEs, graded according to the NCI-CTCAE, Version 5.0
Full Information
NCT ID
NCT04601857
First Posted
October 15, 2020
Last Updated
October 5, 2023
Sponsor
Taiho Oncology, Inc.
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04601857
Brief Title
Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
Official Title
A Phase 2 Study Evaluating Futibatinib (TAS 120) Plus Pembrolizumab in the Treatment of Advanced or Metastatic Urothelial Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced and Metastatic Urothelial Cancer
Keywords
Futibatinib, Pembrolizumab, Urothelial cancer, FGFR, TAS120, MK3475 B04
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
futibatinib and pembrolizumab (Cohort A)
Arm Type
Experimental
Arm Description
Patients with UC and FGFR3 mutation or FGFR1-4 fusion/rearrangement.
Arm Title
futibatinib and pembrolizumab (Cohort B)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
futibatinib and pembrolizumab
Other Intervention Name(s)
TAS120 and MK3475
Intervention Description
Patients will receive futibatinib at an oral dose of 20 mg daily and pembrolizumab at an intravenous dose of 200 mg every 3 weeks
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Objective response rate (ORR), defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR).
Time Frame
Approximately 12 months
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
DCR defined as the proportion of patients experiencing a best overall response of stable disease (SD), PR, or CR.
Time Frame
Approximately 8 months
Title
Duration of response (DOR)
Description
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.
Time Frame
Approximately 8 months
Title
Progression-free survival (PFS)
Description
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.
Time Frame
Approximately 8 months
Title
Overall survival (OS)
Description
OS defined as the time from the date of the first dose to the death date.
Time Frame
Approximately 18 months
Title
Incidence of treatment-emergent Adverse Events (AE)[Safety and Tolerability]
Description
Safety and tolerability of the futibatinib and pembolizumab combination therapy based on reported AEs, graded according to the NCI-CTCAE, Version 5.0
Time Frame
Approximately 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taiho Oncology, INC
Phone
1-609-250-7336
Email
clinicaltrialinfo@taihooncology.com
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vadim Koshkin
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Terminated
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clara Hwang
Facility Name
Comprehensive Care Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Goodman Jr.
Facility Name
ICANS - Institut de cancérologie de Strasbourg Europe
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Barthelemy
Facility Name
Institut Paoli Calmettes - Hôpital de jour
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwenaelle Gravis
Facility Name
Centre Georges-François Leclerc
City
Dijon
State/Province
Côte d'Or
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Leon Berard - departement d'oncologie medicale
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aude Flechon
Facility Name
Centre Regional de Lutte Contre le Cancer de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionnel Geoffrois
Facility Name
Institut De Cancerologie Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohann Loriot
Facility Name
ALTHAIA, Xarxa Assistencial Universitària de Manresa
City
Manresa
State/Province
Brcelona
ZIP/Postal Code
8243
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montserrat Domenech
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Begoña Mellado
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Morales Barrera
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María José Méndez Vidal
Facility Name
Hospital Universitario HMN Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Durán
Facility Name
Hospital la Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Regina Gironés Sarrió
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
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