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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04601857
Recruitment Status : Active, not recruiting
First Posted : October 26, 2020
Last Update Posted : April 12, 2024
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced and Metastatic Urothelial Cancer Drug: futibatinib and pembrolizumab (KEYTRUDA®)) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Evaluating Futibatinib (TAS 120) Plus Pembrolizumab in the Treatment of Advanced or Metastatic Urothelial Carcinoma
Actual Study Start Date : January 21, 2021
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : June 30, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: futibatinib and pembrolizumab (Cohort A)
Patients with UC and FGFR3 mutation or FGFR1-4 fusion/rearrangement.
 Drug: futibatinib and pembrolizumab (KEYTRUDA®))
Patients will receive futibatinib at an oral dose of 20 mg daily and pembrolizumab at an intravenous dose of 200 mg every 3 weeks
Other Name: TAS120 and MK-3475-B04
Experimental: futibatinib and pembrolizumab (Cohort B)
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).
 Drug: futibatinib and pembrolizumab (KEYTRUDA®))
Patients will receive futibatinib at an oral dose of 20 mg daily and pembrolizumab at an intravenous dose of 200 mg every 3 weeks
Other Name: TAS120 and MK-3475-B04


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 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 :
  1. Disease control rate (DCR) [ Time Frame: Approximately 8 months ]
    DCR defined as the proportion of patients experiencing a best overall response of stable disease (SD), PR, or CR.

  2. Duration of response (DOR) [ Time Frame: 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.

  3. Progression-free survival (PFS) [ Time Frame: 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.

  4. Overall survival (OS) [ Time Frame: Approximately 18 months ]
    OS defined as the time from the date of the first dose to the death date.

  5. Incidence of treatment-emergent Adverse Events (AE)[Safety and Tolerability] [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide written informed consent for the trial.
  2. Age ≥ 18 years of age

  3. Histologically confirmed advanced or metastatic urothelial carcinoma who have not received systemic treatment for advanced metastatic disease.

    1. Cohort A: must have an FGFR3 mutation or FGFR1-4 fusion/rearrangement.
    2. 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)
  4. Unfit for or intolerant to standard platinum-based chemotherapy.
  5. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
  6. Adequate organ function.
  7. Have a measurable disease per RECIST 1.1

Exclusion Criteria:

  1. Have received prior therapy with anti-PD-1, anti-PD-L1/L2 agent or FGFR inhibitor.

  2. History and/or current evidence of any of the following disorders:

    1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator.
    2. Ectopic mineralization/calcification considered clinically significant in the opinion of the Investigator.
    3. Retinal or corneal disorder considered clinically significant in the opinion of the Investigator.
  3. Has received a live vaccine within 30 days prior to the first dose of study drug.
  4. Have an active autoimmune disease that has required systemic treatment in the past 2 years.
  5. Have a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
  6. Have had an allogenic tissue/ organ transplant.
  7. 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.
  8. Have known active central nervous system metastases and/or carcinomatous meningitis.
  9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
  10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601857


Locations
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Sponsors and Collaborators
Taiho Oncology, Inc.
Merck Sharp & Dohme LLC
More Information
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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04601857    
Other Study ID Numbers: TAS-120-203
2020-000945-15 ( EudraCT Number )
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taiho Oncology, Inc.:
Futibatinib
Pembrolizumab
Urothelial cancer
 FGFR
TAS120
MK3475 B04
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pembrolizumab
 Futibatinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action