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Brief Title: Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer
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 ID: NCT02954991
Brief Summary: The study will evaluate the clinical activity of nivolumab in combination with 3 separate investigational agents, glesatinib, sitravatinib, or mocetinostat.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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