The purpose of this study is to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.
Participants greater than or equal to (>=)18 years of age on the day of signing informed consent (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
Able to understand and willing to provide consent using the study Informed Consent Form (ICF). The voluntarily signed ICF must be obtained before any study-specific procedures are performed.
Histologically or cytologically confirmed Stage IIB, Stage IIC, Stage III, or Stage IV melanoma (per American Joint Committee on Cancer, 8th edition) that was completely surgically resected. Complete surgical resection requires removal of all clinically or radiographically evident regional disease. Completion of lymph node dissection is not required unless clinically indicated. Participants must have been surgically rendered free of disease with negative margins on resected specimens documented by appropriate pathology and surgical reports.
Complete surgical resection of melanoma must have been performed within 12 weeks before randomization.
History of ocular/uveal melanoma.
Participants with an active, known, or suspected autoimmune disease are to be excluded from participation. Participants who have received systemic treatment for an autoimmune disease within the past 2 years before randomization (eg, with disease-modifying agents, corticosteroids, or immunosuppressive drugs) are also excluded.
History of active malignancy other than melanoma under study within 3 years before randomization, except for locally curable early-stage cancers (carcinoma in situ or Stage I) that have been curatively treated, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
Participants with a condition requiring systemic treatment with either corticosteroids >10 mg daily prednisone or equivalent or other immunosuppressive medications within 14 days before randomization. Inhaled or topical steroids, and adrenal replacement steroid doses <=10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease
Parallel
Bmab1700
DrugIntravenous infusion.
Opdivo
DrugIntravenous infusion.
Area Under the Concentration-Time Curve from Time 0 (Day 1) To Day 29 After the First Dose (AUC0-28days) of Bmab 1700 and Opdivo
Area Under the Concentration-Time Curve Over a Dosing Interval (AUC0-tau) of Bmab 1700 and Opdivo
Maximum Observed Serum Concentration (Cmax) of Bmab 1700 and Opdivo
Time to Reach the Maximum Serum Concentration (Tmax) of Bmab 1700 and Opdivo
Maximum Observed Plasma Concentration (Cmaxss) of Bmab 1700 and Opdivo at Steady State
Time to Reach the Maximum Serum Concentration (Tmaxss) of Bmab 1700 and Opdivo at Steady State
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