Study Stopped
This study was terminated as a result of Sponsor portfolio reprioritization.
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
1 other identifier
interventional
161
1 country
25
Brief Summary
The study will evaluate the clinical activity of nivolumab in combination with 3 separate investigational agents, glesatinib, sitravatinib, or mocetinostat.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2016
Longer than P75 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2016
CompletedFirst Posted
Study publicly available on registry
November 4, 2016
CompletedStudy Start
First participant enrolled
November 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2021
CompletedResults Posted
Study results publicly available
April 22, 2024
CompletedApril 22, 2024
April 1, 2024
5 years
November 2, 2016
January 26, 2024
April 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
ORR is defined as the percentage of participants that were documented to have a confirmed complete response (CR) or partial response (PR) as defined by RECIST v1.1.
Up to 40.6 months
Secondary Outcomes (5)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Day 1 up to 28 days after the last dose (median time on treatment was: CIT experienced 3.7 months; CIT naĂ¯ve 4.8 months)
Duration of Response (DOR)
Up to 38.8 months
Progression Free Survival (PFS)
Up to 40.6 months
Overall Survival (OS)
Up to 43.8 months
Blood Plasma Concentrations
Cycle 1 Day 1 through Cycle 5 Day 1
Study Arms (3)
Glesatinib and Nivolumab
EXPERIMENTALGlesatinib oral tablet administered twice daily in combination with Nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week
Sitravatinib and Nivolumab
EXPERIMENTALSitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week
Mocetinostat and Nivolumab
EXPERIMENTALMocetinostat oral capsule administered three times weekly in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week
Interventions
Glesatinib is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Mocetinostat is an HDAC inhibitor.
nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Eligibility Criteria
You may qualify if:
- Diagnosis of non-small cell lung cancer.
- Prior treatment with a checkpoint inhibitor (as appropriate per cohort)
- Adequate bone marrow and organ function
You may not qualify if:
- Uncontrolled tumor in the brain
- Unacceptable toxicity with prior checkpoint inhibitor
- Impaired heart function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Yuma Regional Medical Center
Yuma, Arizona, 85364, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
University of California San Diego
La Jolla, California, 92093, United States
University of California San Francisco Comprehensive Cancer Center
San Francisco, California, 94115, United States
University of California Los Angeles - Torrance - Community Cancer Care
Santa Clarita, California, 91355, United States
Rocky Mountain Cancer Centers - Denver - Midtown
Denver, Colorado, 80218, United States
Baptist Health
Louisville, Kentucky, 40207, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Saint Francis Cancer Treatment Center
Grand Island, Nebraska, 68803, United States
Oncology Hematology Care-Blue Ash
Cincinnati, Ohio, 45242, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Hematology Oncology Associates - Barnett Office
Medford, Oregon, 97504, United States
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, 97062, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Vanderbilt University
Nashville, Tennessee, 37212, United States
Texas Oncology - South Austin
Austin, Texas, 78745, United States
USOR - Texas Oncology - Denison Cancer Center
Denison, Texas, 75020, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Virginia Cancer Specialist
Fairfax, Virginia, 22031, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Enrollment into glesatinib cohorts was discontinued in November 2017 as a result of Sponsor portfolio reprioritization. The analysis and reporting of this treatment arm is limited and will be summarized for selected tables only.
Results Point of Contact
- Title
- Clinical Operations Director
- Organization
- Mirati Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2016
First Posted
November 4, 2016
Study Start
November 7, 2016
Primary Completion
November 4, 2021
Study Completion
November 4, 2021
Last Updated
April 22, 2024
Results First Posted
April 22, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share