Melanoma Clinical Trial
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
The purpose of this study is to compare the drug levels of nivolumab administered subcutaneously versus intravenous administration in participants with melanoma following complete resection.
Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins
Complete resection performed within 12 weeks prior to randomization or treatment assignment
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
History of uveal or mucosal melanoma
Untreated/unresected CNS metastases or leptomeningeal metastases
Active, known or suspected autoimmune disease
Serious or uncontrolled medical disorder 4 weeks prior to screening
Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible
Prior immunotherapy treatments for any prior malignancies are not permitted
Other protocol-defined inclusion/exclusion criteria apply
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There are 16 Locations for this study
Fort Wayne Indiana, 46804, United States
Knoxville Tennessee, 37920, United States
Coffs Harbour New South Wales, 2450, Australia
Wollongong New South Wales, 2500, Australia
Bendigo Victoria, 3550, Australia
Gent , 9000, Belgium
Milano , 20141, Italy
Napoli , 80131, Italy
Opole Opolskie, 45-06, Poland
Bydgoszcz , 85-79, Poland
Barcelona , 08003, Spain
Madrid , 28036, Spain
Madrid , 28050, Spain
Sevilla , 41009, Spain
Valencia , 46014, Spain
Leicester Leicestershire, LE1 5, United Kingdom
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