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Trial record 1 of 1 for:    516-005 | Recruiting Studies | Interventional Studies
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Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous NSCLC

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

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 in combination with checkpoint inhibitor therapy.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Biological: Nivolumab Drug: Sitravatinib Drug: Docetaxel Phase 3

Detailed Description:
Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs, including the TAM family (TYRO3, AXL and MERTK), VEGFR2, KIT and MET. 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.

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Study Type : Interventional
Estimated Enrollment : 664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 in Combination With Checkpoint Inhibitor Therapy
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 at 120 mg once daily.
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 several closely related receptor tyrosine kinases.
Other Name: MGCD516

Active Comparator: Docetaxel
Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.
Drug: Docetaxel
Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.
Other Name: Taxotere




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 36 Months ]
    OS is defined as time from date of randomization to date of death due to any cause


Secondary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: 36 Months ]
    Frequency of patient experiencing treatment-emergent AEs

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
  • Receipt of prior first-line treatment with platinum-based chemotherapy in combination with PD-1/PD-L1 checkpoint inhibitor therapy
  • Adequate bone marrow and organ function
  • Candidate to receive docetaxel as second 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 in the first-line setting
  • Impaired heart function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906071


Contacts
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Contact: Mirati Therapeutics Study Locator Services 1-844-893-5530 miratistudylocator@emergingmed.com

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Sponsors and Collaborators
Mirati Therapeutics Inc.
Bristol-Myers Squibb

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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03906071     History of Changes
Other Study ID Numbers: 516-005
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mirati Therapeutics Inc.:
Sitravatinib
Nivolumab
Docetaxel
Checkpoint inhibitor
MGCD516
NSCLC
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Nivolumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological