Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

Completed · Phase 3 · Has a placebo group

Conditions studied: Melanoma

In brief

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

Key facts

Study ID

NCT02388906

Run by

Bristol-Myers Squibb

People needed

906

Starts

2015-03-16

Expected to finish

2024-10-16

Last updated by the study team

2025-04-24

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age
• Completely removed melanoma by surgery performed within 12 weeks of randomization
• Stage IIIb/C or Stage IV before complete resection
• No previous anti-cancer treatment

You may not qualify if…

• Ocular or uveal melanoma
• History of carcinomatosis meningitis
• History of auto-immune disease
• Treatment directed against the resected melanoma that is administrated after the surgery
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0117 — La Jolla, California, United States
• Local Institution - 0189 — Los Angeles, California, United States
• Local Institution - 0021 — San Francisco, California, United States
• Local Institution - 0006 — San Francisco, California, United States
• Local Institution - 0010 — Aurora, Colorado, United States
• Local Institution - 0004 — Washington D.C., District of Columbia, United States
• Local Institution - 0012 — Jacksonville, Florida, United States
• Local Institution - 0019 — Miami Beach, Florida, United States
• Local Institution - 0030 — Orlando, Florida, United States
• Local Institution - 0032 — Tampa, Florida, United States
• Local Institution - 0016 — Atlanta, Georgia, United States
• Local Institution - 0106 — Chicago, Illinois, United States
• Local Institution - 0013 — Boston, Massachusetts, United States
• Local Institution - 0170 — Boston, Massachusetts, United States
• Local Institution - 0171 — Boston, Massachusetts, United States
• Local Institution - 0015 — Ann Arbor, Michigan, United States
• Local Institution - 0002 — Robbinsdale, Minnesota, United States
• Local Institution - 0017 — St Louis, Missouri, United States
• Local Institution - 0123 — Hackensack, New Jersey, United States
• Local Institution - 0095 — New Brunswick, New Jersey, United States
• Local Institution - 0024 — New York, New York, United States
• Local Institution - 0033 — New York, New York, United States
• Local Institution - 0003 — Charlotte, North Carolina, United States
• Local Institution - 0025 — Durham, North Carolina, United States
• Local Institution - 0036 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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