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Trial ID CA209-067  |   NCT01844505

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

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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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Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologically confirmed stage III (unresectable) or stage IV melanoma - Treatment naïve patients - Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria - Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: - Active brain metastases or leptomeningeal metastases - Ocular melanoma - Subjects with active, known or suspected autoimmune disease - Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment - 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab

ASSIGNED INTERVENTION
  • Biological: Placebo for Ipilimumab, Nivolumab, Placebo for Nivolumab

Study Arms

Experimental: Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab

ASSIGNED INTERVENTION
  • Biological: Ipilimumab, Nivolumab, Placebo for Nivolumab

Study Arms

Experimental: Arm C: Ipilimumab+Placebo for Nivolumab

ASSIGNED INTERVENTION
  • Biological: Ipilimumab, Placebo for Nivolumab