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

Part of paid clinical trials in Yuma, Arizona.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT02954991
Phase
PHASE2
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glesatinib — DRUG
    Glesatinib is a small molecule multi-targeted receptor tyrosine kinase inhibitor
  • Sitravatinib — DRUG
    Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
  • Mocetinostat — DRUG
    Mocetinostat is an HDAC inhibitor.
  • Nivolumab — DRUG
    nivolumab is a programmed death receptor-1 (PD-1) blocking antibody

Study Details

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

Key Dates

Start date
Nov 7, 2016
Status verified
Apr 2024
Primary completion
Nov 4, 2021
Completion
Nov 4, 2021

Study Design

Enrollment
161 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glesatinib and Nivolumab
    Glesatinib oral tablet administered twice daily in combination with Nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week
  • Experimental: Sitravatinib and Nivolumab
    Sitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week
  • Experimental: Mocetinostat and Nivolumab
    Mocetinostat 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

Primary Outcome Measure

Objective Response Rate (ORR) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. [ Time Frame: Up to 40.6 months ]

Locations (25)

FacilityCityStateZIPSite coordinators
Yuma Regional Medical CenterYumaArizona85364-
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
City of Hope National Medical CenterDuarteCalifornia91010-
University of California San DiegoLa JollaCalifornia92093-
University of California San Francisco Comprehensive Cancer CenterSan FranciscoCalifornia94115-
University of California Los Angeles - Torrance - Community Cancer CareSanta ClaritaCalifornia91355-
Rocky Mountain Cancer Centers - Denver - MidtownDenverColorado80218-
Baptist HealthLouisvilleKentucky40207-
Henry Ford HospitalDetroitMichigan48202-
Minnesota Oncology Hematology, P.A.MinneapolisMinnesota55404-
University of Minnesota Masonic Cancer CenterMinneapolisMinnesota55455-
Saint Francis Cancer Treatment CenterGrand IslandNebraska68803-
Oncology Hematology Care-Blue AshCincinnatiOhio45242-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Hematology Oncology Associates - Barnett OfficeMedfordOregon97504-
Northwest Cancer Specialists, P.C.TualatinOregon97062-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Vanderbilt UniversityNashvilleTennessee37212-
Texas Oncology - South AustinAustinTexas78745-
USOR - Texas Oncology - Denison Cancer CenterDenisonTexas75020-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology - TylerTylerTexas75702-
Virginia Cancer SpecialistFairfaxVirginia22031-
University of WisconsinMadisonWisconsin53792-

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