Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Mirati Therapeutics Inc.
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT02954991
First received: November 2, 2016
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
The study will evaluate the clinical activity of nivolumab in combination with 3 separate investigational agents, glesatinib, sitravatinib, or mocetinostat.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Mirati Therapeutics Inc.:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 209
Study Start Date: November 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Contact: Nuzhat Siddiqui    205-975-2618    nuzhat@uab.edu   
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Nisha Parikh    858-822-3171    nrparikh@ucsd.edu   
United States, Michigan
Henry Ford Hospial Recruiting
Detroit, Michigan, United States, 48202
Contact: Igor Rybkin, MD, PhD         
United States, Virginia
Virginia Cancer Specialist Recruiting
Fairfax, Virginia, United States, 22031
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cancer Connect    608-262-5223      
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
Study First Received: November 2, 2016
Last Updated: March 9, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on April 28, 2017