Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

Official Title

A Randomized Phase 3 Study of Sitravatinib in Combination With Nivolumab Versus Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy SAPPHIRE

Details

Sitravatinib (MGCD516) is an orally-available, small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, TAM (Tyro3, AXL, MERTK) family, VEGFR family, PDGFR family, KIT, FLT3, TRK family, RET, DDR2, and selected EPH family members. Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.

Keywords

Metastatic Non-Squamous Non-Small Cell Lung Cancer Sitravatinib Nivolumab Docetaxel Checkpoint inhibitor MGCD516 NSCLC SAPPHIRE Lung Neoplasms Carcinoma, Non-Small-Cell Lung Nivolumab and Sitravatinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
  • Receipt of at least one but not more than two prior treatment regimens in the advanced setting
  • Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy)
  • Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment
  • Candidate to receive docetaxel as second or third line therapy

You CAN'T join if...

  • Uncontrolled brain metastases
  • Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
  • Unacceptable toxicity with prior checkpoint inhibitor therapy
  • Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
  • Impaired heart function

Locations

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90024 United States
  • Beverly Hills Cancer Center accepting new patients
    Beverly Hills California 90211 United States
  • California Cancer Associates for Research and Excellence - Fresno Cancer Center accepting new patients
    Fresno California 93720 United States
  • Los Angeles Hematology Oncology Medical Group accepting new patients
    Los Angeles California 90017 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirati Therapeutics Inc.
ID
NCT03906071
Phase
Phase 3
Study Type
Interventional
Last Updated