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

Completed · Phase 3 · Has a placebo group

Conditions studied: Unresectable or Metastatic Melanoma

In brief

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 facts

Study ID

NCT01844505

Run by

Bristol-Myers Squibb

People needed

945

Starts

2013-06-11

Expected to finish

2024-04-19

Last updated by the study team

2025-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• Local Institution - 0046 — La Jolla, California, United States
• Local Institution - 0053 — Los Angeles, California, United States
• Local Institution - 0014 — Los Angeles, California, United States
• Comprehensive Cancer Center At Desert Regional Medical Ctr — Palm Springs, California, United States
• Local Institution - 0066 — Rancho Mirage, California, United States
• California Pacific Medical Center Research Institute — San Francisco, California, United States
• Local Institution - 0049 — San Francisco, California, United States
• Local Institution - 0052 — Aurora, Colorado, United States
• Local Institution - 0084 — New Haven, Connecticut, United States
• Local Institution - 0098 — Washington D.C., District of Columbia, United States
• Local Institution - 0183 — Washington D.C., District of Columbia, United States
• Local Institution - 0042 — Jacksonville, Florida, United States
• Local Institution - 0008 — Orlando, Florida, United States
• Local Institution - 0051 — Atlanta, Georgia, United States
• Maine Center For Cancer Medicine — Scarborough, Maine, United States
• Local Institution - 0080 — Lutherville, Maryland, United States
• Local Institution - 0081 — Boston, Massachusetts, United States
• Local Institution - 0082 — Boston, Massachusetts, United States
• Local Institution - 0083 — Boston, Massachusetts, United States
• Local Institution - 0087 — Ann Arbor, Michigan, United States
• Local Institution - 0187 — Minneapolis, Minnesota, United States
• Local Institution - 0065 — Jackson, Mississippi, United States
• Local Institution - 0067 — St Louis, Missouri, United States
• Local Institution - 0085 — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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