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

This study is currently recruiting participants.
Verified November 2017 by Mirati Therapeutics Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02954991
First Posted: November 4, 2016
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mirati Therapeutics Inc.
November 2, 2016
November 4, 2016
November 6, 2017
November 2016
April 2018   (Final data collection date for primary outcome measure)
Number of patients experiencing tumor size reduction [ Time Frame: Up to 3 months ]
Same as current
Complete list of historical versions of study NCT02954991 on ClinicalTrials.gov Archive Site
  • Number of patients experiencing adverse events [ Time Frame: up to 12 months ]
  • Blood plasma concentration of the investigational agent [ Time Frame: Up to 20 weeks ]
Same as current
Not Provided
Not Provided
 
Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer
A Parallel Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Advanced or Metastatic 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.

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 or 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 being 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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: Glesatinib
    Glesatinib is a small molecule multi-targeted receptor tyrosine kinase inhibitor
    Other Name: MGCD265
  • Drug: Sitravatinib
    Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
    Other Name: MGCD516
  • Drug: Mocetinostat
    Mocetinostat is an HDAC inhibitor.
    Other Name: MGCD01013
  • Drug: Nivolumab
    nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
    Other Name: Opdivo
  • Experimental: Glesatinib and Nivolumab
    Glesatinib oral tablet administered twice daily in combination with Nivolumab administered as 240 mg IV every 2 weeks
    Interventions:
    • Drug: Glesatinib
    • Drug: Nivolumab
  • Experimental: Sitravatinib and Nivolumab
    Sitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks
    Interventions:
    • Drug: Sitravatinib
    • Drug: Nivolumab
  • Experimental: Mocetinostat and Nivolumab
    Mocetinostat oral capsule administered three times weekly in combination with nivolumab administered as 240 mg IV every 2 weeks
    Interventions:
    • Drug: Mocetinostat
    • Drug: Nivolumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
209
April 2019
April 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncontrolled tumor in the brain
  • Unacceptable toxicity with prior checkpoint inhibitor
  • Impaired heart function
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
Contact: Mirati Therapeutics Study Locator Services 1-844-356-0895 (toll free) miratistudylocator@emergingmed.com
United States
 
 
NCT02954991
MRTX-500
No
Not Provided
Plan to Share IPD: No
Mirati Therapeutics Inc.
Mirati Therapeutics Inc.
Not Provided
Not Provided
Mirati Therapeutics Inc.
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP