The study will evaluate the clinical activity of nivolumab in combination with 3 separate
investigational agents, glesatinib, sitravatinib, or mocetinostat.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02954991.
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.
Lead OrganizationMirati Therapeutics