Pharmacokinetics, Pharmacodynamics, and Safety of Nivolumab in Patients With Sepsis-Induced Immunosuppression: A Multicenter, Open-Label Phase 1/2 Study.

ABSTRACT:

Background

Sepsis often induces an immunosuppressive state, which is associated with high mortality rates. Immunostimulation may be beneficial for sepsis. We investigated the pharmacokinetics, pharmacodynamics, and safety of nivolumab, a human programmed death-1 immune checkpoint inhibitor approved for the treatment of several cancers.

Methods

In this multicenter, open-label phase 1/2 study, a single 480 or 960 mg nivolumab dose was intravenously infused into Japanese patients with immunosuppressive sepsis. Doses were selected to mimic the exposure achieved with the approved dosage for cancer patients (3 mg/kg every 2 weeks [Q2W]).

Results

Single 480 and 960 mg nivolumab doses were intravenously infused into five and eight patients, respectively. The maximum concentra

SUBMITTER: Watanabe E 

PROVIDER: S-EPMC7448837 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature