Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Melanoma
Age (in years)
12+
Phase
Phase 3
Participants needed
790
Est. Completion Date
Jun 29, 2027
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT04099251
Study number
CA20976K
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