Clinical Trials /

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

NCT02954991

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02954991

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: MRTX-500
  • NCT ID: NCT02954991

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
GlesatinibMGCD265Glesatinib and Nivolumab
SitravatinibMGCD516Sitravatinib and Nivolumab
MocetinostatMGCD01013Mocetinostat and Nivolumab
NivolumabOpdivoGlesatinib and Nivolumab

Purpose

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

Detailed Description

      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.

Trial Arms

NameTypeDescriptionInterventions
Glesatinib and NivolumabExperimentalGlesatinib oral tablet administered twice daily in combination with Nivolumab administered as 240 mg IV every 2 weeks
  • Glesatinib
  • Nivolumab
Sitravatinib and NivolumabExperimentalSitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks
  • Sitravatinib
  • Nivolumab
Mocetinostat and NivolumabExperimentalMocetinostat oral capsule administered three times weekly in combination with nivolumab administered as 240 mg IV every 2 weeks
  • Mocetinostat
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of non-small cell lung cancer.

          -  Prior treatment with a checkpoint inhibitor (as appropriate per cohort)

          -  Adequate bone marrow and organ function

        Exclusion Criteria:

          -  Uncontrolled tumor in the brain

          -  Unacceptable toxicity with prior checkpoint inhibitor

          -  Impaired heart function
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients experiencing tumor size reduction
Time Frame:Approximately 8 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of patients experiencing adverse events
Time Frame:up to 12 months
Safety Issue:
Description:
Measure:Blood plasma concentration of the investigational agent
Time Frame:Up to 20 weeks
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Progression free survival
Time Frame:Up to 12 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Mirati Therapeutics Inc.

Last Updated

August 24, 2021