A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma

NOT ENROLLING
Protocol # :
19-494
Conditions
Melanoma
Phase
III
Disease Sites
Melanoma, Skin
Principal Investigator
Ott, Patrick
Site Investigator
Mooradian, Meghan, J.
Site Research Nurses
Finn, Kristen
Furtado, Mollie, E.
Gormley, Jill, Kathleen
Livengood, Amanda
Mossali, Alexandra

Trial Description

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 Requirements

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.

19-494