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

Trial Status: Active

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.

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

Colorado

Aurora
University of Colorado Hospital
Status: APPROVED

Illinois

Chicago
Northwestern University
Status: IN_REVIEW

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: APPROVED

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA209-76K
  • Secondary IDs NCI-2019-08256, 2019-001230-34
  • Clinicaltrials.gov ID NCT04099251