ArticleJournal for immunotherapy of cancer2019
Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies.
Article in Journal for immunotherapy of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02013804 (A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0680), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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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.
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- High-dimensional analysis of the adenosine pathway in high-grade serous ovarian cancer.Journal for immunotherapy of cancer · 2021Pooled it
- Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy from a First-in-Human Study of Volrustomig, a Novel PD-1/CTLA-4 Bispecific Antibody.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Trial
- Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species.PLoS pathogens · 2022Trial
- CCR5 Receptor Occupancy Analysis Reveals Increased Peripheral Blood CCR5+CD4+ T Cells Following Treatment With the Anti-CCR5 Antibody Leronlimab.Frontiers in immunology · 2021Trial
- Pharmacovigilance insights into drug-induced hypercalcemia: evidence from the U.S. FDA Adverse Event Reporting System (FAERS) database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Observational
- Immunotherapy-Associated Cardiotoxicity: Current Insights and Future Directions for Precision Cardio-Oncology.Cancers · 2025Review
- Targeting highly attenuated IL-18 to PD-1 for enhanced anti-tumor activity.Frontiers in immunology · 2025Article
- Perspective: Pathological transdifferentiation-a novel therapeutic target for cardiovascular diseases and chronic inflammation.Frontiers in cardiovascular medicine · 2024Article
- Identification and construction of a 13-gene risk model for prognosis prediction in hepatocellular carcinoma patients.Journal of clinical laboratory analysis · 2022Article
- Analyzing and validating the prognostic value and immune microenvironment of clear cell renal cell carcinoma.Animal cells and systems · 2022Article
- Review
- A human receptor occupancy assay to measure anti-PD-1 binding in patients with prior anti-PD-1.Cytometry. Part A : the journal of the International Society for Analytical Cytology · 2021Article
- Antibody-based CCR5 blockade protects Macaques from mucosal SHIV transmission.Nature communications · 2021Article
- Phase I, first-in-human trial of programmed cell death receptor-1 (PD-1) inhibitor, JTX-4014, in adult patients with advanced, refractory, solid tumors.Cancer immunology, immunotherapy : CII · 2021Article
Corrections and comments
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Authors and funding
21 authors.
Funding
Abstract
backgroundThe safety, efficacy, pharmacokinetics, and pharmacodynamics of the anti-programmed cell death-1 antibody MEDI0680 were evaluated in a phase I, multicenter, dose-escalation study in advanced solid malignancies.
methodsMEDI0680 was administered intravenously once every 2 weeks (Q2W) or once every 3 weeks at 0.1, 0.5, 2.5, 10 or 20 mg/kg. Two cohorts received 20 mg/kg once a week for 2 or 4 weeks, then 20 mg/kg Q2W. All were treated for 12 months or until progression. The primary endpoint was safety. Secondary endpoints were efficacy and pharmacokinetics. Exploratory endpoints included pharmacodynamics.
resultsFifty-eight patients were treated. Median age was 62.5 years and 81% were male. Most had kidney cancer (n = 36) or melanoma (n = 9). There were no dose-limiting toxicities. Treatment-related adverse events occurred in 83% and were grade ≥ 3 in 21%. Objective clinical responses occurred in 8/58 patients (14%): 5 with kidney cancer, including 1 with a complete response, and 3 with melanoma. The relationship between dose and serum levels was predictable and linear, with apparent receptor saturation at 10 mg/kg Q2W and all 20 mg/kg cohorts.
conclusionsMEDI0680 induced peripheral T-cell proliferation and increased plasma IFNγ and associated chemokines regardless of clinical response. CD8+ T-cell tumor infiltration and tumoral gene expression of IFNG, CD8A, CXCL9, and granzyme K (GZMK) were also increased following MEDI0680 administration.
trial registrationNCT02013804 ; date of registration December 12, 2013.
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