Trial reportIntensive care medicine2019
Immune checkpoint inhibition in sepsis: a Phase 1b randomized study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of nivolumab.
Trial report in Intensive care medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02960854 (Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936558), which is not on this map. Cited by 129 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936558 (Nivolumab) in Participants With Severe Sepsis or Septic Shock.
Who cites it
129 citing papers in PubMed, 6 syntheses or guidelines pooled it, 184 citations in OpenAlex.
- Surviving Sepsis Campaign International Guidelines for the Management of Sepsis and Septic Shock in Children 2026.Intensive care medicine · 2026Pooled it
- A bibliometric and visual analysis of research trends and hotspots in sepsis-related immunosuppression (2005-2025).Frontiers in pharmacology · 2026Pooled it
- Assessing Monoclonal and Polyclonal Antibodies in Sepsis and Septic Shock: A Systematic Review of Efficacy and Safety.International journal of molecular sciences · 2025Pooled it
- Anti-PD-L1 Therapy Does Not Improve Survival in a Murine Model of Lethal Staphylococcus aureus Pneumonia.The Journal of infectious diseases · 2021Pooled it
- Potential Targets to Mitigate Trauma- or Sepsis-Induced Immune Suppression.Frontiers in immunology · 2021Pooled it
- Inhibitory Immune Checkpoint Molecule Expression in Clinical Sepsis Studies: A Systematic Review.Critical care medicine · 2020Pooled it
- Immune enhancement in patients with predicted severe acute necrotising pancreatitis: a multicentre double-blind randomised controlled trial.Intensive care medicine · 2022Trial
- [Pharmacological immunomodulation in sepsis].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2026Review
- Restricted TCR Diversity and Expansion of CD177MedComm · 2026Article
- High Frequencies of Senescent and Exhausted Natural Killer Cells and SARS-CoV-2-Specific Memory CD8Viruses · 2026Article
- Host-directed immune therapies: a second front in the battle against sepsis.The Journal of clinical investigation · 2026Review
- Emerging evidence for anti-PD-1 and IFN-γ as adjunctive immunotherapy in invasive mold infections.mBio · 2026Article
- Age-related differences and common pathways of lymphocyte subsets in sepsis: a comparative review of elderly and pediatric patients.Cell death & disease · 2026Review
- Interventional Effects of Edible Bird's Nest or Sialic Acids on Sepsis-Induced Immunosuppression in Mice.Food science & nutrition · 2026Article
- Review
- The Dual Role of Interleukin-10 in Sepsis: Research Progress and Therapeutic Prospects.Inflammation · 2026Review
- Immunology of Sepsis.Clinics in chest medicine · 2026Review
- HDAC1 modulates sepsis-induced immunosuppression by driving the exhaustion of CD8+ T cells.JCI insight · 2026Article
- 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
- Exploratory characterization of dynamic soluble programmed death-ligand 1 trajectories and their association with mortality in critical coronavirus disease 2019.Journal of intensive care · 2026Article
69 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
20 authors at 13 institutions in 1 country.
Funding
Abstract
purposeSepsis-associated immunosuppression increases hospital-acquired infection and viral reactivation risk. A key underlying mechanism is programmed cell death protein-1 (PD-1)-mediated T-cell function impairment. This is one of the first clinical safety and pharmacokinetics (PK) assessments of the anti-PD-1 antibody nivolumab and its effect on immune biomarkers in sepsis.
methodsRandomized, double-blind, parallel-group, Phase 1b study in 31 adults at 10 US hospital ICUs with sepsis diagnosed ≥ 24 h before study treatment, ≥ 1 organ dysfunction, and absolute lymphocyte count ≤ 1.1 × 10
resultsTwelve deaths occurred [n = 6 per study arm; 40% (480 mg) and 37.5% (960 mg)]. Serious AEs occurred in eight participants [n = 1, 6.7% (480 mg); n = 7, 43.8% (960 mg)]. AEs considered by the investigator to be possibly drug-related and immune-mediated occurred in five participants [n = 2, 13.3% (480 mg); n = 3, 18.8% (960 mg)]. Mean ± SD terminal half-life was 14.7 ± 5.3 (480 mg) and 15.8 ± 7.9 (960 mg) days. All participants maintained > 90% receptor occupancy (RO) 28 days post-infusion. Median (Q1, Q3) mHLA-DR levels increased to 11,531 (6528, 19,495) and 11,449 (6225, 16,698) mAbs/cell in the 480- and 960-mg arms by day 14, respectively. Pro-inflammatory cytokine levels did not increase.
conclusionsIn this sepsis population, nivolumab administration did not result in unexpected safety findings or indicate any 'cytokine storm'. The PK profile maintained RO > 90% for ≥ 28 days. Further efficacy and safety studies are warranted. TRIAL REGISTRATION NUMBER (CLINICALTRIALS.GOV): NCT02960854.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.