Status:
ACTIVE_NOT_RECRUITING
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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 melanom...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2027
Estimated Enrollment :
790 Patients enrolled
Trial Details
Trial ID
NCT04099251
Start Date
October 28 2019
End Date
June 29 2027
Last Update
August 27 2025
Active Locations (130)
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1
Local Institution - 0088
Birmingham, Alabama, United States, 35294-3300
2
Local Institution - 0126
Tucson, Arizona, United States, 85724-5024
3
Local Institution - 0087
Springdale, Arkansas, United States, 72762
4
Local Institution - 0080
Los Angeles, California, United States, 90025