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An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma

NCT03068455

Description:

The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma

Related Conditions:
  • Melanoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
  • Official Title: A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma

Clinical Trial IDs

  • ORG STUDY ID: CA209-915
  • SECONDARY ID: 2016-003729-41
  • NCT ID: NCT03068455

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
nivolumabOpdivo, BMS-936558nivolumab + ipilimumab
ipilimumabYervoy, BMS-734016nivolumab + ipilimumab

Purpose

The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma

Trial Arms

NameTypeDescriptionInterventions
nivolumab + ipilimumabExperimentalSpecified Dose on Specified Days
    nivolumabExperimentalSpecified Dose on Specified Days

      Eligibility Criteria

              For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
              visit www.BMSStudyConnect.com
      
              Inclusion Criteria:
      
                -  Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of
                   participation in study.
      
                -  Must have full activity or, if limited, must be able to walk and carry out activities
                   such as light house work or office work
      
                -  No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s)
                   and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for
                   central nervous system (CNS) lesions)
      
              Exclusion Criteria:
      
                -  History of uveal melanoma
      
                -  Patients with active, known or suspected autoimmune disease
      
                -  Prior treatment with interferon (if complete < 6 months prior to participation in
                   study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any
                   other antibody or drug specifically targeting T-cell co-stimulation or checkpoint
                   pathways
      
              Other protocol defined inclusion/exclusion criteria could apply
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:12 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Recurrence-free survival (RFS)
      Time Frame:Approximately 30 months
      Safety Issue:
      Description:measured by time

      Secondary Outcome Measures

      Measure:Overall Survival (OS)
      Time Frame:Up to 5 years
      Safety Issue:
      Description:measured by time
      Measure:PD-L1 expression
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:measured by immunoassay

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Bristol-Myers Squibb

      Last Updated

      February 22, 2018