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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
261
Specified dose on specified days
Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h)
Time frame: Over the dosing interval at Week 1 and Week 17
Maximum Observed Plasma Concentration (Cmax)
Time frame: Over the dosing interval at Week 1 and Week 17
Observed serum concentration at the end of a dosing interval (Ctau)
Time frame: Over the dosing interval at Week 1 and Week 17
Time of maximum observed plasma concentration (Tmax)
Time frame: Over the dosing interval at Week 1 and Week 17
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Time frame: Through Week 51 Day 1
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 65 weeks
Number of Participants With Adverse Events leading to Discontinuation
Time frame: Up to 65 weeks
Number of Participants With Adverse Events (AEs)
Time frame: Up to 65 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Up to 65 weeks
Number of Participants with AEs leading to death
Time frame: Up to 65 weeks
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Local Institution - 0006
Hartford, Connecticut, United States
Local Institution - 0008
Minneapolis, Minnesota, United States
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Charlotte, North Carolina, United States
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Pittsburgh, Pennsylvania, United States
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Buenos Aires, Argentina
Local Institution - 0001
Wollstonecraft, New South Wales, Australia
Local Institution - 0036
Ijuí, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Barretos, São Paulo, Brazil
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Cerqueira César, São Paulo, Brazil
...and 27 more locations