Date: 2016-11-02
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Mirati Therapeutics (USA - CA)
Product: glesatinib, sitravatinib or mocetinostat in combination with nivolumab
Action
mechanism: immunotherapy product/monoclonal antibody/immune checkpoint inhibitor/HDAC inhibitor/tyrosine kinase inhibitor. Nivolumab is a human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. Mocetinostat is an orally-bioavailable, spectrum-selective HDAC (histone deacetylase) inhibitor. Mocetinostat has completed 13 clinical trials in more than 400 patients with a variety of hematologic malignancies and solid tumors. Mirati is currently conducting Phase 2 studies of mocetinostat as a single agent in patients with bladder cancer and DLBCL. Mocetinostat is also in a Phase 2 dose confirmation study in combination with Vidaza® as treatment for intermediate and high-risk myelodysplastic syndrome (MDS). Glesatinib (MGCD265) is a tyrosine kinase inhibitor that potently and selectively targets tumors in patients with driver alterations in MET (mutations and gene amplification) and AXL (rearrangements and gene amplification) that occur in approximately 8% of patients with non-small cell lung cancer (NSCLC). Genetic alterations in these targets have been implicated as drivers of tumor growth and disease progression in NSCLC and other solid tumors. Sitravatinib is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The study will evaluate the clinical activity of nivolumab in combination with 3 separate investigational agents, glesatinib, sitravatinib, or mocetinostat. (NCT02954991)
Latest
news: * On November 2, 2016, a Phase 2 trial sponsored by Mirati Therapeutics was published on the NIH website ClinicalTrials.gov for glesatinib, sitravatinib or mocetinostat in combination with nivolumab in non-small cell lung cancer and is currently recruiting participants.
