Phase I Pharmacokinetic Study of Nivolumab in Korean Patients with Advanced Solid Tumors.

ABSTRACT: LESSONS LEARNED:This pharmacokinetic study of nivolumab showed that there is little ethnic difference in the handling of nivolumab.Nivolumab was well tolerated in Korean patients. BACKGROUND:This phase I study of nivolumab, an anti-programmed cell death-1 (anti-PD-1) monoclonal antibody, investigated the pharmacokinetics and safety of nivolumab in Korean patients with advanced solid tumors. Findings were compared with results from Japan and the U.S. MATERIALS AND METHODS:In this two-part study, patients received a single dose of nivolumab (1, 3, and 10 mg/kg; ONO-4538-13) and were followed up for 3 weeks. Those who met the required criteria proceeded to the second part (ONO-4538-14), and received the same dose as in part one every 2 weeks. RESULTS:Six patients per dose level were enrolled

SUBMITTER: Lee KW 

PROVIDER: S-EPMC5813749 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature