Trial reportShock (Augusta, Ga.)2020
Pharmacokinetics, Pharmacodynamics, and Safety of Nivolumab in Patients With Sepsis-Induced Immunosuppression: A Multicenter, Open-Label Phase 1/2 Study.
Trial report in Shock (Augusta, Ga.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
46 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A bibliometric and visual analysis of research trends and hotspots in sepsis-related immunosuppression (2005-2025).Frontiers in pharmacology · 2026Pooled it
- Review
- Myeloid-derived suppressor cells in sepsis: drivers of persistent immunosuppression and targets for precision immunotherapy.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026Review
- Immunology of Sepsis.Clinics in chest medicine · 2026Review
- Cancer Patients with Sepsis: Prognostic Insights from a Population-Based Cohort Study in Norway.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2026Article
- Immune checkpoint inhibitors in infectious diseases: therapeutic reinvigoration, immunopathology, and precision targeting.Frontiers in immunology · 2026Review
- Endothelial cell, but not neutrophil, programmed cell death receptor-ligand 1 loss has a morbid impact on experimental murine shock/sepsis-induced lung injury.Frontiers in immunology · 2026Article
- Transcending metabolic acidosis: lactate as an epigenetic signal reprogramming diabetes-sepsis immunity.Frontiers in immunology · 2026Review
- When to initiate immunomodulatory therapy in sepsis.Frontiers in immunology · 2026Review
- Monitoring immune cell dynamics for potential prognostic biomarker of sepsis.BMC infectious diseases · 2025Article
- Immune Dysregulation in Sepsis. A Narrative Review for the Clinicians.Biomedicines · 2025Review
- The Role of Vitamin D and Vitamin D Receptor in Sepsis.Current issues in molecular biology · 2025Review
- Physiologically Based Pharmacokinetic Models for Infliximab, Ipilimumab, and Nivolumab Developed with GastroPlus to Predict Hepatic Concentrations.Pharmaceutics · 2025Article
- Targeting sepsis through inflammation and oxidative metabolism.World journal of critical care medicine · 2025Review
- Review
- Emerging antimicrobial therapies for Gram-negative infections in human clinical use.npj antimicrobials and resistance · 2025Review
- Clinical management of sepsis-associated acute respiratory distress syndrome: current evidence and future directions.Frontiers in medicine · 2025Review
- Recent advances of precision immunotherapy in sepsis.Burns & trauma · 2025Review
- Immune signatures of sepsis from mild infection to critical illness - a prospective observational study.Frontiers in immunology · 2025Observational
- Mechanistic and therapeutic dimensions of DcR3-mediated immunomodulation in sepsis.Frontiers in immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSepsis 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.
methodsIn 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]).
resultsSingle 480 and 960 mg nivolumab doses were intravenously infused into five and eight patients, respectively. The maximum concentration after 480 mg (132 μg/mL) was similar to the predicted concentration at the end of infusion with 3 mg/kg Q2W (117 μg/mL). The concentration on Day 28 after 960 mg (33.1 μg/mL) was within the predicted trough concentration range for 3 mg/kg Q2W (90% prediction interval 19.0-163 μg/mL). Absolute lymphocyte counts and monocyte human leukocyte antigen-DR subtype expression levels appeared to increase over time. The incidences of adverse events (AEs) were 80% and 50% in the 480 mg and 960 mg groups, respectively. Drug-related AEs were observed in only one patient in the 480 mg group. No deaths related to nivolumab occurred.
conclusionsA single dose of 960 mg nivolumab appeared to be well tolerated and sufficient to maintain nivolumab blood concentrations. Both 480 mg and 960 mg nivolumab seemed to improve immune system indices over time.
trial registrationJAPIC, JapicCTI-173600.
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