Summary

for people ages 18-100 (full criteria)
at UCLA UCSF UCSD
study started
estimated completion:

Description

Summary

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

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

Details

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.

Keywords

Carcinoma, Non-Small-Cell Lung Nivolumab Antibodies, Monoclonal Mocetinostat Glesatinib Sitravatinib Glesatinib and Nivolumab Sitravatinib and Nivolumab Mocetinostat and Nivolumab

Eligibility

You can join if…

Open to people ages 18-100

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

You CAN'T join if...

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

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • University of California San Francisco Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • Beverly Hills Cancer Center accepting new patients
    Beverly Hills California 90211 United States
  • Providence Saint Joseph Medical Center accepting new patients
    Burbank California 91505 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirati Therapeutics Inc.
ID
NCT02954991
Phase
Phase 2
Study Type
Interventional
Last Updated