Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

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About the study

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  • For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  • Inclusion Criteria:


    1. Histologically confirmed stage III (unresectable) or stage IV melanoma
    2. Treatment naïve patients
    3. Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
    4. Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
    5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

    EXCLUSION CRITERIA

    Exclusion Criteria:


    1. Active brain metastases or leptomeningeal metastases
    2. Ocular melanoma
    3. Subjects with active, known or suspected autoimmune disease
    4. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
    5. Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition
    Unresectable or Metastatic Melanoma
    Age (in years)
    18+
    Phase
    Phase 3
    Participants needed
    1296
    Est. Completion Date
    Oct 31, 2024
    Treatment type
    Interventional

    Sponsor
    Bristol-Myers Squibb
    ClinicalTrials.gov identifier
    NCT01844505
    Study number
    CA209067

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