Trial reportJournal for immunotherapy of cancer2025
Pharmacokinetics and safety of subcutaneous nivolumab: results from the phase I/II CheckMate 8KX study.
Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03656718 (Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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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.
Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Transition from Parenteral to Subcutaneous Application of Systemic Oncological Therapy for Treating Non-Small-Cell Lung Cancer.Current oncology (Toronto, Ont.) · 2026Pooled it
- Model-Informed Development of a Subcutaneous Formulation of Tislelizumab: Phase 1 Pharmacokinetics in Patients With Cancer.Clinical and translational science · 2026Trial
- Model-based clinical pharmacology profiling of subcutaneous nivolumab in renal cell carcinoma: Bridging to alternative dosing regimens and indications.Clinical pharmacology and therapeutics · 2026Article
- Subcutaneously Administered Tislelizumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer: Pharmacokinetics and Safety Results from the BGB-A317-103 Phase I Study.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Pros and cons of subcutaneous (SC) versus intravenous (IV) administration of immune checkpoint inhibitors in non-small cell lung cancer.Translational lung cancer research · 2024Article
- Subcutaneous delivery of immune checkpoint inhibitors: new route replacing intravenous administration?Translational lung cancer research · 2024Article
Corrections and comments
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Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCheckMate 8KX was a phase I/II study investigating the pharmacokinetics and safety of subcutaneous (SC) nivolumab±recombinant human hyaluronidase PH20 (rHuPH20).
methodsPatients with advanced solid tumors who were immune-checkpoint inhibitor-naïve were included. In parts A and B, patients received one single dose of nivolumab SC 720 mg or 960 mg±rHuPH20 2000 U/mL followed by nivolumab intravenous (IV) 480 mg every 4 weeks (Q4W). Patients receiving nivolumab IV could switch to nivolumab SC 1200 mg+rHuPH20 2000 U/mL Q4W in part C. Patients in part D received nivolumab SC 1200 mg+rHuPH20 Q4W. The primary objective was to describe the pharmacokinetics of nivolumab SC±rHuPH20. Secondary objectives included assessing safety and immunogenicity of nivolumab SC. Exploratory objectives included evaluating patient experience and preference and characterizing biomarker measures of immune function (pretreatment and on-treatment peripheral blood and tumor biopsies).
resultsA total of 103 patients with various solid tumor types were treated between December 4, 2018 and September 7, 2022. Mean duration of injection was <5 min for nivolumab SC±rHuPH20. Nivolumab exposures over the first dosing interval increased with increasing dose; geometric-mean time to maximum concentration across doses was 117-167 hours (5-7 days). Nivolumab SC+rHuPH20 was well tolerated; grade 3/4 treatment-related adverse events occurred in 0%-11.1% of patients; antidrug antibodies were reported in some patients but were not associated with altered safety; no neutralizing antibodies were detected. Overall, patients preferred SC delivery over IV or had no preference. Increased tumor and peripheral pharmacodynamic biomarkers were observed postnivolumab SC, consistent with historical data for nivolumab IV.
conclusionThe pharmacokinetics of nivolumab SC have been well characterized and enabled dose selection for further study. Nivolumab SC has an acceptable safety profile, allows for rapid administration, and is preferred by more patients than nivolumab IV. These results encourage large-scale investigation of nivolumab SC. TRIAL REGISTRATION NUMBER: NCT03656718.
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