Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT04099251
This study evaluates nivolumab's effectiveness as adjuvant immunotherapy versus placebo in adults and pediatric participants post-complete resection of Stage IIB/C melanoma. Eligible participants must have a negative sentinel lymph node biopsy, no prior melanoma treatment, ECOG 0 or 1, and confirmed resected Stage IIB/C melanoma. Interventions include specified doses of nivolumab or placebo.
Patient Parameters
| Parameter | Options |
|---|
Program 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.
Eligibility 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
- 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0088 | 35294-3300 | Birmingham | Alabama |
| Local Institution - 0126 | 85724-5024 | Tucson | Arizona |
| Local Institution - 0087 | 72762 | Springdale | Arkansas |
| Local Institution - 0080 | 90025 | Los Angeles | California |
| Local Institution - 0077 | 94115 | San Francisco | California |
| Local Institution - 0119 | 94115 | San Francisco | California |
| Local Institution - 0122 | 95119 | San Jose | California |
| Local Institution - 0121 | 94589-2441 | Vallejo | California |
| Local Institution - 0109 | 94589 | Vallejo | California |
| Local Institution - 0120 | 94589 | Vallejo | California |
Get This Program In Your Inbox
You can sign up and apply your patients for this program.