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



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:3/8/2019
Start Date:November 2016
End Date:April 2020
Contact:Mirati Therapeutics Study Locator Services
Email:miratistudylocator@emergingmed.com
Phone:1-844-893-5530 (toll free)

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

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

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.

Inclusion Criteria:

- Diagnosis of non-small cell lung cancer.

- Prior treatment with platinum based doublet and checkpoint inhibitor

- Adequate bone marrow and organ function

Exclusion Criteria:

- Uncontrolled tumor in the brain

- Unacceptable toxicity with prior checkpoint inhibitor

- Impaired heart function
We found this trial at
24
sites
2800 North Highway 75
Sherman, Texas 75090
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Austin, Texas 78745
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Beverly Hills, California 90211
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Birmingham, Alabama 35294
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Birmingham, AL
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501 S Buena Vista St
Burbank, California 91505
(818) 843-5111
Providence Saint-Joseph Medical Center Located just north of Los Angeles, Providence Saint Joseph Medical Center...
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Burbank, CA
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Cincinnati, OH
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Cleveland, OH
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Columbus, OH
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Denver, CO
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duarte, CA
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Fairfax, Virginia 22031
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Fairfax, VA
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Grand Island, Nebraska 68803
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Grand Island, NE
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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Louisville, Kentucky
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Louisville, KY
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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2828 East Barnett Road
Medford, Oregon 97504
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Medford, OR
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Minneapolis, Minnesota 55405
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Minneapolis, MN
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Minneapolis, Minnesota 55455
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Minneapolis, MN
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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San Francisco, CA
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Tualatin, Oregon 97062
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Tualatin, OR
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Tyler, Texas 75702
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Tyler, TX
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