ArticleESMO open2016
Safety and immunogenicity of the PRAME cancer immunotherapeutic in metastatic melanoma: results of a phase I dose escalation study.
Article in ESMO open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01149343 (Study of GSK2302025A Antigen-Specific Cancer Immunotherapeutic in Patients With Metastatic Melanoma), which is not on this map. Cited by 42 papers.
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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.
Study of GSK2302025A Antigen-Specific Cancer Immunotherapeutic in Patients With Metastatic Melanoma
Who cites it
42 citing papers in PubMed, 73 citations in OpenAlex.
- Characterization and comparison of innate and adaptive immune responses at vaccine sites in melanoma vaccine clinical trials.Cancer immunology, immunotherapy : CII · 2021Trial
- Targeting the C/EBPβ-PRAME-EZH2 complex modulates the Netrin-4/AKT axis to inhibit renal cancer tumorigenesis and metastasis.Cell death and differentiation · 2026Article
- PRAME immunohistochemistry demonstrates high diagnostic accuracy for distinguishing melanoma from nevi but no observed association with pT stage in cutaneous melanoma: a Vietnamese clinicopathological study.Diagnostic pathology · 2026Article
- TIME for Endometrial Cancer: Advancements and Challenges in Therapeutic Targets for the Endometrial Cancer Tumor Immune Microenvironment.Cancer immunology research · 2025Review
- PRAME Immunohistochemical Expression in Recurrent/Traumatized Melanocytic Nevi and the Pitfall of Expression by Reactive Fibroblasts.Dermatology practical & conceptual · 2025Article
- Key Biomarker Correlations in Cutaneous Melanoma: Implications for Diagnostic, Prognostic, and Therapeutic Strategies-A Retrospective Single-Centered Study.Medicina (Kaunas, Lithuania) · 2025Article
- Nested Melanoma and Superficial Spreading Melanoma with Prominent Nests-A Retrospective Study on Clinical Characteristics and PRAME Expression.Diagnostics (Basel, Switzerland) · 2025Article
- PRAME Expression in Melanoma is Negatively Regulated by TET2-Mediated DNA Hydroxymethylation.Laboratory investigation; a journal of technical methods and pathology · 2025Article
- Individualized Neoantigen-Directed Melanoma Therapy.American journal of clinical dermatology · 2025Review
- TLR9: A Double-Dealing Toll-Like Receptor.ImmunoTargets and therapy · 2025Review
- Review
- PRAME expression in melanoma is negatively regulated by TET2-mediated DNA hydroxymethylation.bioRxiv : the preprint server for biology · 2024Article
- Article
- High-affinity T cell receptor ImmTAC® bispecific efficiently redirects T cells to kill tumor cells expressing the cancer-testis antigen PRAME.Immunotherapy advances · 2024Article
- PRAME Expression: A Target for Cancer Immunotherapy and a Prognostic Factor in Uveal Melanoma.Investigative ophthalmology & visual science · 2023Article
- Immunohistochemical expression of PRAME in 485 cases of epithelial tubo-ovarian tumors.Virchows Archiv : an international journal of pathology · 2023Article
- PRAME immunohistochemistry in soft tissue tumors and mimics: a study of 350 cases highlighting its imperfect specificity but potentially useful diagnostic applications.Virchows Archiv : an international journal of pathology · 2023Article
- PRAME Staining in Sinonasal Mucosal Melanoma: A Single-Center Experience.Head and neck pathology · 2023Article
- HDAC5-mediated PRAME regulates the proliferation, migration, invasion, and EMT of laryngeal squamous cell carcinoma via the PI3K/AKT/mTOR signaling pathway.Open medicine (Warsaw, Poland) · 2023Article
- PRAME immunohistochemistry compared to traditional FISH testing in spitzoid neoplasms and other difficult to diagnose melanocytic neoplasms.Frontiers in medicine · 2023Article
Corrections and comments
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Authors and funding
25 authors at 17 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe PRAME tumour antigen is expressed in several tumour types but in few normal adult tissues. A dose-escalation phase I/II study (NCT01149343) assessed the safety, immunogenicity and clinical activity of the PRAME immunotherapeutic (recombinant PRAME protein (recPRAME) with the AS15 immunostimulant) in patients with advanced melanoma. Here, we report the phase I dose-escalation study segment. PATIENTS AND
methodsPatients with stage IV PRAME-positive melanoma were enrolled to 3 consecutive cohorts to receive up to 24 intramuscular injections of the PRAME immunotherapeutic. The RecPRAME dose was 20, 100 or 500 µg in cohorts 1, 2 and 3, respectively, with a fixed dose of AS15. Adverse events (AEs), including predefined dose-limiting toxicity (DLT) and the anti-PRAME humoral response (ELISA), were coprimary end points. Cellular immune responses were evaluated using in vitro assays.
results66 patients were treated (20, 24 and 22 in the respective cohorts). AEs considered by the investigator to be causally related were mostly grade 1 or 2 injection site symptoms, fatigue, chills, fever and headache. Two DLTs (grade 3 brain oedema and proteinuria) were recorded in two patients in two cohorts (cohorts 2 and 3). All patients had detectable anti-PRAME antibodies after four immunisations. Percentages of patients with predefined PRAME-specific-CD4+T-cell responses after four immunisations were similar in each cohort. No CD8+ T-cell responses were detected.
conclusionsThe PRAME immunotherapeutic had an acceptable safety profile and induced similar anti-PRAME-specific humoral and cellular immune responses in all cohorts. As per protocol, the phase II study segment was initiated to further evaluate the 500 µg PRAME immunotherapeutic dose. TRIAL REGISTRATION NUMBER: NCT01149343, Results.
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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.