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

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Status: Closed to Accrual

Description

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.

Eligibility Criteria

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

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-067
Secondary IDs NCI-2013-01254, 2012-005371-13
Clinicaltrials.gov ID NCT01844505

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