Trial reportBritish journal of clinical pharmacology2014
Model-based clinical pharmacology profiling of ipilimumab in patients with advanced melanoma.
Trial report in British journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 3 of them syntheses 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
59 citing papers in PubMed, 3 syntheses or guidelines pooled it, 94 citations in OpenAlex.
- Pooled it
- A model-based meta-analysis of immune-related adverse events during immune checkpoint inhibitors treatment for NSCLC.CPT: pharmacometrics & systems pharmacology · 2022Pooled it
- Population pharmacokinetic meta-analysis of ramucirumab in cancer patients.British journal of clinical pharmacology · 2017Pooled it
- CX-072 (pacmilimab), a Probody PD-L1 inhibitor, in combination with ipilimumab in patients with advanced solid tumors (PROCLAIM-CX-072): a first-in-human, dose-finding study.Journal for immunotherapy of cancer · 2021Trial
- Population Pharmacokinetic Analysis of Pexidartinib in Healthy Subjects and Patients With Tenosynovial Giant Cell Tumor or Other Solid Tumors.Journal of clinical pharmacology · 2021Trial
- An open-label, multiple ascending dose study of the anti-CTLA-4 antibody ipilimumab in viremic HIV patients.PloS one · 2018Trial
- Article
- Quantitative Systems Pharmacology Model Predicts Enhanced Antitumor Efficacy of Combined Cytotoxic T‑Lymphocyte-Associated Protein 4 (CTLA-4) and Programmed Cell Death Protein 1 (PD-1) Blockade in a Syngeneic Mouse Model of Breast Cancer.ACS pharmacology & translational science · 2026Article
- Overall survival according to timing of immune checkpoint inhibitors administration in patients with advanced cancer: results from a large single-centre cohort analysis.British journal of cancer · 2026Article
- Population pharmacokinetics for the CTLA-4 modulator gotistobart in patients with advanced solid tumors.Journal of clinical pharmacology · 2026Article
- First-in-human study of intravenous bispecific CTLA-4 × OX40 antibody (ATOR-1015) in advanced solid malignancies.ESMO open · 2026Article
- Exposure-response relationship of sintilimab in advanced gastric cancer: insights from time-dependent pharmacokinetics and biomarker integration for precision immunotherapy.Frontiers in pharmacology · 2026Review
- Ipilimumab and nivolumab for cancer treatment: a pharmacovigilance study based on the FDA adverse event reporting system database.Frontiers in endocrinology · 2026Article
- Article
- Mechanism-Based Modeling Approaches to Quantify the Effect of Immunogenicity on the Pharmacokinetics of Therapeutic Proteins in Drug Development.CPT: pharmacometrics & systems pharmacology · 2025Review
- Inter-Antibody Variability in the Clinical Pharmacokinetics of Monoclonal Antibodies Characterized Using Population Physiologically Based Pharmacokinetic Modeling.Antibodies (Basel, Switzerland) · 2024Article
- Utility and impact of quantitative pharmacology on dose selection and clinical development of immuno-oncology therapy.Cancer chemotherapy and pharmacology · 2024Review
- Antibody Drug Clearance: An Underexplored Marker of Outcomes with Checkpoint Inhibitors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Review
- Therapeutic drug monitoring of immunotherapies with novel Affimer-NanoBiT sensor construct.Sensors & diagnostics · 2024Article
- Metabolic modulation of melanoma enhances the therapeutic potential of immune checkpoint inhibitors.Frontiers in oncology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimIpilimumab is a fully human, monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4. The objective of the present study was to characterize the clinical pharmacology profile of ipilimumab using a population pharmacokinetic (PPK) approach.
methodsThe PPK model was developed using 2095 ipilimumab serum concentration values from 499 patients with unresectable stage III or IV melanoma from four phase II studies, with ipilimumab doses ranging from 0.3 to 10 mg kg(-1) . The structural PK model was determined by developing a base PPK model. The effect of covariates on model parameters was assessed by a full covariate model, which incorporated all pre-specified covariate-parameter relationships into the base model. The final model was developed by backward elimination, followed by exclusion of covariates determined not to be of clinical relevance to ipilimumab, and was rigorously validated against both internal and external datasets.
resultsIpilimumab PK was linear and time-invariant, with dose-proportional exposures over the available dose range, yielding a terminal half-life of approximately 15 days. Clearance of ipilimumab increased with increasing body weight and baseline serum lactate dehydrogenase concentrations, but was not affected by age, gender, concomitant budesonide, Eastern Cooperative Oncology Group performance status or prior systemic anticancer therapy. Furthermore, ipilimumab exposure was not affected by moderate renal impairment or mild hepatic impairment.
conclusionsIpilimumab concentration-time data were well described by a linear, two compartment, zero order i.v. infusion model. The model confirms that a body weight-normalized dosing regimen is appropriate for ipilimumab therapy in patients with advanced melanoma.
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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.