Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
Phase 3 – large-scale trial before approval
Conditions:
Melanoma
Sponsor: Bristol-Myers Squibb
trial.available_in:
БГ
Overview
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 participate
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:
* 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.