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

Trial Status: Active

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

Inclusion Criteria

  • Diagnosis of non-small cell lung cancer.
  • Prior treatment with a checkpoint inhibitor
  • Adequate bone marrow and organ function

Exclusion Criteria

  • Uncontrolled tumor in the brain
  • Unacceptable toxicity with prior checkpoint inhibitor
  • Impaired heart function

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Lia Etheridge
Phone: 310-825-7174
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL
Contact: Hatim Husain
Phone: 858-822-5354
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: COMPLETED

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Mirati Therapeutics

  • Primary ID MRTX-500
  • Secondary IDs NCI-2016-01892
  • Clinicaltrials.gov ID NCT02954991