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

Purpose

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.

Condition

  • Melanoma

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 could apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nivolumab
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
Placebo Comparator
Placebo
  • Other: Placebo
    Specified dose on specified days

Recruiting Locations

University Of Alabama At Birmingham
Birmingham, Alabama 35294
Contact:
Ashley Holder, Site 0088
205-978-2848

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
please email
Clinical.Trials@bms.com