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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02954991
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE November 2, 2016
First Posted Date  ICMJE November 4, 2016
Last Update Posted Date April 19, 2022
Study Start Date  ICMJE November 2016
Actual Primary Completion Date November 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2021)
Number of patients experiencing tumor size reduction [ Time Frame: Approximately 8 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
Number of patients experiencing tumor size reduction [ Time Frame: Up to 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • 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 ]
  • Overall Survival [ Time Frame: Up to 24 months ]
  • Progression free survival [ Time Frame: Up to 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer
Official Title  ICMJE A Parallel Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Advanced or Metastatic Non-Small Cell Lung Cancer
Brief Summary 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:

Enrollment into glesatinib cohort was discontinued and enrollment to mocetinostat cohort will not initiate at this time.

Recruitment to final cohort ended in accordance with administrative letter dated 15Sept2020

Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2022)
211
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2016)
209
Actual Study Completion Date  ICMJE November 4, 2021
Actual Primary Completion Date November 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02954991
Other Study ID Numbers  ICMJE MRTX-500
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Mirati Therapeutics Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mirati Therapeutics Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mirati Therapeutics Inc.
Verification Date April 2022

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