Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in 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.
- Carcinoma, Non-Small-Cell Lung
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Diagnosis of non-small cell lung cancer.
- Prior treatment with platinum based doublet and checkpoint inhibitor
- Adequate bone marrow and organ function
- Uncontrolled tumor in the brain
- Unacceptable toxicity with prior checkpoint inhibitor
- Impaired heart function
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Glesatinib and Nivolumab
|Glesatinib oral tablet administered twice daily in combination with Nivolumab administered as 240 mg IV every 2 weeks||
Sitravatinib and Nivolumab
|Sitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks||
Mocetinostat and Nivolumab
|Mocetinostat oral capsule administered three times weekly in combination with nivolumab administered as 240 mg IV every 2 weeks||
- NCT ID
- Mirati Therapeutics Inc.
Study ContactMirati Therapeutics Study Locator Services
1-844-893-5530 (toll free)
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.