Melanoma Clinical Trial
A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection
Summary
The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed stage IIIa/b/c/d or stage IV melanoma
Complete resection of Stage III disease that is documented on the surgical and pathology reports or complete resection of Stage IV disease with margins negative for disease that is documented on the pathology report
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion Criteria:
Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured
Any significant acute or chronic medical illness that is uncontrolled
History of ocular/uveal melanoma
Active, known or suspected autoimmune disease
Systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.
Other protocol-defined inclusion/exclusion criteria apply
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There are 33 Locations for this study
Hartford Connecticut, 06106, United States
Minneapolis Minnesota, 55407, United States
Charlotte North Carolina, 28204, United States
Pittsburgh Pennsylvania, 15213, United States
Buenos Aires , 1431, Argentina
Wollstonecraft New South Wales, 2065, Australia
Ijui RIO Grande DO SUL, 98700, Brazil
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Barretos Sao Paulo, 14780, Brazil
Cerqueira Cesar SAO Paulo, 01246, Brazil
São José do Rio Preto São Paulo, 15090, Brazil
Rio de Janeiro , 20230, Brazil
Edmonton , T6X 1, Canada
Santiago Metropolitana, 84203, Chile
Santiago Metropolitana, , Chile
Independencia Santiago, , Chile
Santiago , 0, Chile
Marseille Cedex 5 , 13385, France
Nantes Cedex 1 , 44093, France
Paris , 75475, France
Wilton Cork, T12 D, Ireland
Dublin , , Ireland
Bergamo , 24127, Italy
Padova , 35128, Italy
Siena , 53100, Italy
Tlalpan Distrito Federal, 14080, Mexico
Monterrey Nuevo Leon, 64460, Mexico
San Pedro Garza Garcia Nuevo LEON, 66278, Mexico
Auckland , 1023, New Zealand
Christchurch , 0, New Zealand
Wellington , 6021, New Zealand
Warszawa , 02-78, Poland
Timisoara , 30069, Romania
Badalona-barcelona , 08916, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Malaga , 29010, Spain
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