Clinical Trials /

An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

NCT03001882

Description:

The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
  • Official Title: An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

  • ORG STUDY ID: CA209-592
  • NCT ID: NCT03001882

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS-936558Nivolumab/Ipilimumab Combination
IpilimumabYervoy, BMS-734016Nivolumab/Ipilimumab Combination

Purpose

The purpose of this study is to explore the possible links between patient characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in patients with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).

Trial Arms

NameTypeDescriptionInterventions
Nivolumab/Ipilimumab CombinationExperimental

    Eligibility Criteria

            For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
            visit www.BMSStudyConnect.com
    
            Inclusion Criteria:
    
              -  Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no
                 prior systemic anticancer therapy given as primary therapy for advanced or metastatic
                 disease
    
              -  Measurable disease by CT or MRI
    
              -  Must have full activity or, if limited, must be able to walk and carry out light
                 activities such as light house work or office work
    
            Exclusion Criteria:
    
              -  Patients with untreated central nervous system metastases
    
              -  Participants with active, known or suspected autoimmune disease
    
              -  Prior treatment with any drug that targets T cell co-stimulations pathways (such as
                 checkpoint inhibitors)
    
            Other protocol defined inclusion/exclusion criteria could apply
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Objective Response Rate (ORR)
    Time Frame:Approximately 48 months
    Safety Issue:
    Description:measured by time

    Secondary Outcome Measures

    Measure:Objective Response Rate (ORR) of patient subgroups defined by baseline biomarkers
    Time Frame:Approximately 48 months
    Safety Issue:
    Description:measured by time
    Measure:Disease Control Rate (DCR) of patient subgroups defined by baseline biomarkers
    Time Frame:Approximately 48 months
    Safety Issue:
    Description:measured by time
    Measure:Duration of Response (DOR) of patient subgroups defined by baseline biomarkers
    Time Frame:Approximately 48 months
    Safety Issue:
    Description:measured by time
    Measure:Time to Response (TTR) of patient subgroups defined by baseline biomarkers
    Time Frame:Approximately 48 months
    Safety Issue:
    Description:measured by time
    Measure:Progression Free Survival (PFS) of patient subgroups defined by baseline biomarkers
    Time Frame:Approximately 48 months
    Safety Issue:
    Description:measured by time
    Measure:Overall Survival (OS) of patient subgroups defined by baseline biomarkers
    Time Frame:Approximately 48 months
    Safety Issue:
    Description:measured by time

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Bristol-Myers Squibb

    Last Updated

    April 19, 2017