Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer
NCT ID: NCT02954991
Last Updated: 2024-04-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
161 participants
INTERVENTIONAL
2016-11-07
2021-11-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glesatinib and Nivolumab
Glesatinib oral tablet administered twice daily in combination with Nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week
Glesatinib
Glesatinib is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Nivolumab
nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Sitravatinib and Nivolumab
Sitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week
Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Nivolumab
nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Mocetinostat and Nivolumab
Mocetinostat oral capsule administered three times weekly in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week
Mocetinostat
Mocetinostat is an HDAC inhibitor.
Nivolumab
nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Interventions
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Glesatinib
Glesatinib is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Mocetinostat
Mocetinostat is an HDAC inhibitor.
Nivolumab
nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior treatment with a checkpoint inhibitor (as appropriate per cohort)
* Adequate bone marrow and organ function
Exclusion Criteria
* Unacceptable toxicity with prior checkpoint inhibitor
* Impaired heart function
18 Years
ALL
No
Sponsors
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Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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Yuma Regional Medical Center
Yuma, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
City of Hope National Medical Center
Duarte, California, United States
University of California San Diego
La Jolla, California, United States
University of California San Francisco Comprehensive Cancer Center
San Francisco, California, United States
University of California Los Angeles - Torrance - Community Cancer Care
Santa Clarita, California, United States
Rocky Mountain Cancer Centers - Denver - Midtown
Denver, Colorado, United States
Baptist Health
Louisville, Kentucky, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Saint Francis Cancer Treatment Center
Grand Island, Nebraska, United States
Oncology Hematology Care-Blue Ash
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Hematology Oncology Associates - Barnett Office
Medford, Oregon, United States
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
Texas Oncology - South Austin
Austin, Texas, United States
USOR - Texas Oncology - Denison Cancer Center
Denison, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Virginia Cancer Specialist
Fairfax, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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MRTX-500
Identifier Type: -
Identifier Source: org_study_id
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