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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02954991
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Glesatinib Drug: Sitravatinib Drug: Mocetinostat Drug: Nivolumab Phase 2

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 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 209 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Glesatinib and Nivolumab
Glesatinib oral tablet administered twice daily in combination with Nivolumab administered as 240 mg IV every 2 weeks
Drug: Glesatinib
Glesatinib is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Other Name: MGCD265
Drug: Nivolumab
nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Other Name: Opdivo
Experimental: Sitravatinib and Nivolumab
Sitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks
Drug: Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Other Name: MGCD516
Drug: Nivolumab
nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Other Name: Opdivo
Experimental: Mocetinostat and Nivolumab
Mocetinostat oral capsule administered three times weekly in combination with nivolumab administered as 240 mg IV every 2 weeks
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


Outcome Measures

Primary Outcome Measures :
  1. Number of patients experiencing tumor size reduction [ Time Frame: Up to 3 months ]

Secondary Outcome Measures :
  1. Number of patients experiencing adverse events [ Time Frame: up to 12 months ]
  2. Blood plasma concentration of the investigational agent [ Time Frame: Up to 20 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954991


Contacts
Contact: Mirati Therapeutics Study Locator Services 1-844-356-0895 (toll free) miratistudylocator@emergingmed.com

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
United States, California
Beverly Hills Cancer Center Recruiting
Beverly Hills, California, United States, 90211
University of California San Diego Recruiting
La Jolla, California, United States, 92093
United States, Colorado
Rocky Mountain Cancer Centers - Denver - Midtown Recruiting
Denver, Colorado, United States, 80218
United States, Michigan
Henry Ford Hospial Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Minnesota Oncology Hematology, P.A. Recruiting
Minneapolis, Minnesota, United States, 55404
University of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
United States, Oregon
Hematology Oncology Associates - Barnett Office Recruiting
Medford, Oregon, United States, 97504
Northwest Cancer Specialists, P.C. Recruiting
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Texas Oncology - South Austin Recruiting
Austin, Texas, United States, 78745
USOR - Texas Oncology - Sherman Recruiting
Sherman, Texas, United States, 75090
Texas Oncology - Tyler Recruiting
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Cancer Specialist Recruiting
Fairfax, Virginia, United States, 22031
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Mirati Therapeutics Inc.
More Information

Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02954991     History of Changes
Other Study ID Numbers: MRTX-500
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Antibodies, Monoclonal
Mocetinostat
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action