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Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer

Sponsor
Mirati Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02954991
Collaborator
(none)
211
Enrollment
24
Locations
3
Arms
60.1
Duration (Months)
8.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate the clinical activity of nivolumab in combination with 3 separate investigational agents, glesatinib, sitravatinib, or mocetinostat.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Glesatinib is an orally administered multi-targeted tyrosine kinase inhibitor (TKI) that primarily targets the Axl and Mesenchymal-Epithelial Transition (MET) receptors. Sitravatinib is an orally-available, potent small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, Axl, MERTK, VEGFR family, PDGFR family, KIT, FLT3, Trk family, RET, DDR2 and selected Eph family members. Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Nivolumab is a human IgG monoclonal antibody that binds to the programmed cell death-1(PD-1) receptor and blocks its interaction with programmed cell death ligand-1 (PD-L1) and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response including anti-tumor immune response. Combining an immunotherapeutic PD-L1 checkpoint inhibitor with an agent that has both immune modulatory and antitumor properties could enhance the antitumor efficacy observed with either agent alone.

The study will begin with a lead-in dose escalation evaluation of two dose levels of each investigational agent in combination with nivolumab. Following completion of the lead-in dose escalation, enrollment into the Phase 2 study will proceed.

Study Design

Study Type:
Interventional
Actual Enrollment :
211 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Enrollment into glesatinib cohort was discontinued and enrollment to mocetinostat cohort will not initiate at this time. Recruitment to final cohort ended in accordance with administrative letter dated 15Sept2020
Primary Purpose:
Treatment
Official Title:
A Parallel Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Advanced or Metastatic Non-Small Cell Lung Cancer
Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Nov 4, 2021
Actual Study Completion Date :
Nov 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Glesatinib and Nivolumab

Glesatinib oral tablet administered twice daily in combination with Nivolumab administered as 240 mg IV every 2 weeks

Drug: Glesatinib
Glesatinib is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Other Names:
  • MGCD265

    • Drug: Nivolumab
    nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
    Other Names:
  • Opdivo

    		•
    Experimental: Sitravatinib and Nivolumab

    Sitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks

    Drug: Sitravatinib
    Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
    Other Names:
  • MGCD516

    • Drug: Nivolumab
    nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
    Other Names:
  • Opdivo

    		•
    Experimental: Mocetinostat and Nivolumab

    Mocetinostat oral capsule administered three times weekly in combination with nivolumab administered as 240 mg IV every 2 weeks

    Drug: Mocetinostat
    Mocetinostat is an HDAC inhibitor.
    Other Names:
  • MGCD01013

    • Drug: Nivolumab
    nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
    Other Names:
  • Opdivo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients experiencing tumor size reduction [Approximately 8 months]

    Secondary Outcome Measures

    1. Number of patients experiencing adverse events [up to 12 months]

    2. Blood plasma concentration of the investigational agent [Up to 20 weeks]

    3. Overall Survival [Up to 24 months]

    4. Progression free survival [Up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of non-small cell lung cancer.

    • Prior treatment with a checkpoint inhibitor (as appropriate per cohort)

    • Adequate bone marrow and organ function

    Exclusion Criteria:

    • Uncontrolled tumor in the brain

    • Unacceptable toxicity with prior checkpoint inhibitor

    • Impaired heart function

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yuma Regional Medical Center Yuma Arizona United States 85364
    2 Beverly Hills Cancer Center Beverly Hills California United States 90211
    3 City of Hope National Medical Center Duarte California United States 91010
    4 University of California San Diego La Jolla California United States 92093
    5 University of California San Francisco Comprehensive Cancer Center San Francisco California United States 94115
    6 University of California Los Angeles - Torrance - Community Cancer Care Santa Clarita California United States 91355
    7 Rocky Mountain Cancer Centers - Denver - Midtown Denver Colorado United States 80218
    8 Baptist Health Louisville Kentucky United States 40207
    9 Henry Ford Hospital Detroit Michigan United States 48202
    10 Minnesota Oncology Hematology, P.A. Minneapolis Minnesota United States 55404
    11 University of Minnesota Masonic Cancer Center Minneapolis Minnesota United States 55455
    12 Saint Francis Cancer Treatment Center Grand Island Nebraska United States 68803
    13 Oncology Hematology Care-Blue Ash Cincinnati Ohio United States 45242
    14 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    15 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    16 Hematology Oncology Associates - Barnett Office Medford Oregon United States 97504
    17 Northwest Cancer Specialists, P.C. Tualatin Oregon United States 97062
    18 Vanderbilt University Nashville Tennessee United States 37212
    19 Texas Oncology - South Austin Austin Texas United States 78745
    20 MD Anderson Cancer Center Houston Texas United States 77030
    21 USOR - Texas Oncology - Sherman Sherman Texas United States 75090
    22 Texas Oncology - Tyler Tyler Texas United States 75702
    23 Virginia Cancer Specialist Fairfax Virginia United States 22031
    24 University of Wisconsin Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • Mirati Therapeutics Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mirati Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT02954991
    Other Study ID Numbers:
    • MRTX-500
    First Posted:
    Nov 4, 2016
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Nivolumab
    Mocetinostat

    Study Results

    No Results Posted as of Apr 19, 2022