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

NCT04099251

Active Not RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Melanoma

Interventions: Nivolumab, Placebo

Countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland

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 overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (130)

Birmingham, Alabama, United States
Tucson, Arizona, United States
Springdale, Arkansas, United States
Los Angeles, California, United States
San Francisco, California, United States
San Francisco, California, United States
San Jose, California, United States
Vallejo, California, United States
Vallejo, California, United States
Vallejo, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Robbinsdale, Minnesota, United States
Omaha, Nebraska, United States
Hackensack, New Jersey, United States
New York, New York, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Germantown, Tennessee, United States
Austin, Texas, United States
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