Clinical Trials /

Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

NCT02659059

Description:

The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy. The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.

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

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs. Chemotherapy Alone (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
  • Official Title: A Study of Nivolumab in Combination With Ipilimumab (Part 1); and Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs. Chemotherapy Alone (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

  • ORG STUDY ID: CA209-568
  • NCT ID: NCT02659059

Conditions

  • Non-Small-Cell Lung Cancer

Interventions

DrugSynonymsArms
NivolumabBMS-936558, OpdivoNivolumab+Ipilimumab
IpilimumabBMS-734016, YervoyNivolumab+Ipilimumab
Platinum Doublet ChemotherapyNivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy

Purpose

The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy. The purpose of part 2 of this study is to compare overall survival of Nivolumab and ipilimumab combined with a short course of chemotherapy to standard of care chemotherapy in first line stage IV NSCLC.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab+IpilimumabExperimentalPart 1 Specified Dose on Specified Days
    Nivolumab+Ipilimumab + 2 cycles Platinum Doublet ChemotherapyExperimentalPart 2 Specified Dose on Specified Days
    • Platinum Doublet Chemotherapy
    Platinum Doublet ChemotherapyActive ComparatorSpecified Dose on Specified Days
    • Platinum Doublet Chemotherapy

    Eligibility Criteria

            For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation,
            please visit www.BMSStudyConnect.com
    
            Inclusion Criteria:
    
              -  Men and Women ≥ 18 years of age
    
              -  Diagnosed with stage IV Non-Small Cell Lung Cancer
    
              -  Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous
                 concurrent chemoradiation with no further curative options.
    
            Exclusion Criteria:
    
              -  Subjects with untreated CNS metastases are excluded.
    
              -  Subjects with carcinomatous meningitis
    
              -  Subjects with an active, known or suspected autoimmune disease.
    
              -  Subjects with a condition requiring systemic treatment with either corticosteroids ( >
                 10 mg daily prednisone
    
            equivalent) or other immunosuppressive medications within 14 days of first treatment.
    
              -  Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.
    
            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:6 months after the last subject first treatment
    Safety Issue:
    Description:Part 1 -Nivolumab and ipilimumab

    Secondary Outcome Measures

    Measure:Progression free survival (PFS)
    Time Frame:14 months after the last subject first treatment
    Safety Issue:
    Description:
    Measure:Overall Survival (OS)
    Time Frame:14 months after the last subject first treatment]
    Safety Issue:
    Description:
    Measure:Overall Response Rate(ORR)
    Time Frame:14 months after the last subject first treatment
    Safety Issue:
    Description:
    Measure:Lung Cancer Symptom Score (LCSS)
    Time Frame:Up To 24 Weeks
    Safety Issue:
    Description:
    Measure:Average Symptom Burden Index (ASBI)
    Time Frame:Up To 24 Weeks
    Safety Issue:
    Description:

    Details

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

    Last Updated

    July 24, 2017