The purpose of this study is to investigate the pharmacokinetic (PK) similarity and
efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in
subjects with resected advanced melanoma.
Additional locations may be listed on ClinicalTrials.gov for NCT05907122.
Locations matching your search criteria
United States
Maryland
Baltimore
University of Maryland/Greenebaum Cancer CenterStatus: Active
Contact: Margaret Carder
Phone: 410-328-8611
Eligible subjects will be randomized in a 1:1:1 ratio to receive either ABP 206, Food and
Drug Administration (FDA)-licensed nivolumab, or European Union (EU)-authorized
nivolumab.
The treatment period is in alignment with the maximum treatment duration for OPDIVO®
(nivolumab, reference product) in the adjuvant setting for melanoma.
All subjects will be treated until recurrence of disease, unacceptable toxicity, or
subject withdrawal of consent with a maximum of 1 year of treatment.
The total duration of study participation for each subject will be approximately 13
months.
Lead OrganizationAmgen, Inc.