Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Melanoma

In brief

The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.

Key facts

Study ID

NCT04099251

Run by

Bristol-Myers Squibb

People needed

790

Starts

2019-10-28

Expected to finish

2026-11-30

Last updated by the study team

2026-08-07

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Had a negative sentinel lymph node biopsy.
• Participant has not been previously treated for melanoma.
• ECOG 0 or 1.
• Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma.

You may not qualify if…

• History of ocular or mucosal melanoma.
• Pregnant or nursing women.
• Participants with active known or suspected autoimmune disease.
• Known history of allergy or hypersensitivity to study drug components.
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways.
• Other protocol defined inclusion/exclusion criteria apply.

Where it is running

• Local Institution - 0126 — Tucson, Arizona, United States
• Local Institution - 0087 — Springdale, Arkansas, United States
• Local Institution - 0080 — Los Angeles, California, United States
• Local Institution - 0077 — San Francisco, California, United States
• Local Institution - 0119 — San Francisco, California, United States
• Local Institution - 0122 — San Jose, California, United States
• Local Institution - 0121 — Vallejo, California, United States
• Local Institution - 0109 — Vallejo, California, United States
• Local Institution - 0120 — Vallejo, California, United States
• Local Institution - 0091 — Aurora, Colorado, United States
• Local Institution - 0089 — Washington D.C., District of Columbia, United States
• Local Institution - 0141 — Atlanta, Georgia, United States
• Local Institution - 0132 — Chicago, Illinois, United States
• Local Institution - 0135 — Baltimore, Maryland, United States
• Local Institution - 0078 — Boston, Massachusetts, United States
• Local Institution - 0127 — Boston, Massachusetts, United States
• Local Institution - 0143 — Boston, Massachusetts, United States
• Local Institution - 0151 — Minneapolis, Minnesota, United States
• Local Institution - 0081 — Robbinsdale, Minnesota, United States
• Local Institution - 0079 — Omaha, Nebraska, United States
• Local Institution - 0093 — Hackensack, New Jersey, United States
• Local Institution - 0094 — New York, New York, United States
• Local Institution - 0086 — Charlotte, North Carolina, United States
• Local Institution - 0099 — Cleveland, Ohio, United States
• Local Institution - 0088 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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