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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

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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Sorry, this study is no longer accepting new participants, but is still ongoing.
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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.

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: Nivolumab, Placebo for Ipilimumab, Placebo for Nivolumab

Study Arms

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

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

Study Arms

Experimental: Arm C: Ipilimumab+Placebo for Nivolumab

ASSIGNED INTERVENTION
  • Biological: Ipilimumab, Placebo for Nivolumab

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