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Trial record 1 of 1 for:    03906071
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Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (SAPPHIRE)

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ClinicalTrials.gov Identifier: NCT03906071
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : March 12, 2021
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE April 8, 2019
Last Update Posted Date March 12, 2021
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
Overall Survival (OS) [ Time Frame: 36 Months ]
OS is defined as time from date of randomization to date of death due to any cause
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
Overall Survival (OS) [ Time Frame: 36 Months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • Adverse Events (AEs) [ Time Frame: 36 Months ]
    Frequency of patients experiencing treatment-emergent AEs
  • Objective Response Rate (ORR) [ Time Frame: 36 Months ]
    ORR defined as complete response (CR) or partial response (PR) per RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy
  • Progression-Free Survival (PFS) [ Time Frame: 36 months ]
    PFS is defined as the time from randomization to the date of the first documentation of objective disease progression or death due to any cause
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
  • Adverse Events (AEs) [ Time Frame: 36 Months ]
  • Objective Response Rate (ORR) [ Time Frame: 36 Months ]
  • Duration of Response (DOR) [ Time Frame: 36 Months ]
  • Clinical Benefit Rate (CBR) [ Time Frame: 36 Months ]
  • Progression-Free Survival (PFS) [ Time Frame: 36 months ]
  • Blood plasma concentration of MGCD516 (PK) [ Time Frame: 36 Months ]
  • Patient Reported Outcome (PRO) [ Time Frame: 36 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Official Title  ICMJE 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
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Non-Squamous Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.
    Other Name: Opdivo
  • Drug: Sitravatinib
    Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
    Other Name: MGCD516
  • Drug: Docetaxel
    Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.
    Other Name: Taxotere
Study Arms  ICMJE
  • Experimental: Nivolumab and Sitravatinib
    Nivolumab will be administered by intravenous infusion over 30 minutes at 240 mg every 2 weeks or at 480 mg every 4 weeks. Sitravatinib capsules will be administered orally, once daily.
    Interventions:
    • Biological: Nivolumab
    • Drug: Sitravatinib
  • Active Comparator: Docetaxel
    Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.
    Intervention: Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2020)
532
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2019)
664
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mirati Therapeutics Study Locator Services 1-844-893-5530 (toll free) miratistudylocator@emergingmed.com
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Hungary,   Italy,   Netherlands,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03906071
Other Study ID Numbers  ICMJE 516-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mirati Therapeutics Inc.
Study Sponsor  ICMJE Mirati Therapeutics Inc.
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Ronald L. Shazer, MD, MBA Mirati Therapeutics Inc.
PRS Account Mirati Therapeutics Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP