{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Yarchoan M"],"funding":["This study has been funded by Geneos Therapeutics.","NCI NIH HHS"],"pagination":["1044-1053"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11031401"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["30(4)"],"pubmed_abstract":["Programmed cell death protein 1 (PD-1) inhibitors have modest efficacy as a monotherapy in hepatocellular carcinoma (HCC). A personalized therapeutic cancer vaccine (PTCV) may enhance responses to PD-1 inhibitors through the induction of tumor-specific immunity. We present results from a single-arm, open-label, phase 1/2 study of a DNA plasmid PTCV (GNOS-PV02) encoding up to 40 neoantigens coadministered with plasmid-encoded interleukin-12 plus pembrolizumab in patients with advanced HCC previously treated with a multityrosine kinase inhibitor. Safety and immunogenicity were assessed as primary endpoints, and treatment efficacy and feasibility were evaluated as secondary endpoints. The most common treatment-related adverse events were injection-site reactions, observed in 15 of 36 (41.6%) "],"journal":["Nature medicine"],"pubmed_title":["Personalized neoantigen vaccine and pembrolizumab in advanced hepatocellular carcinoma: a phase 1/2 trial."],"pmcid":["PMC11031401"],"funding_grant_id":["P30 CA010815","U01 CA212007","R01 CA285544"],"pubmed_authors":["Cooch N","Weiner DB","Kagohara LT","Rochestie S","Yan J","Bartha G","Connor JT","Gane EJ","Northcott J","Marron TU","Jaffee EM","Perales-Puchalt A","Perales-Linares R","Shu DH","Sardesai NY","Csiki I","Fertig EJ","Peters J","Lyle J","Yarchoan M"],"additional_accession":[]},"is_claimable":false,"name":"Personalized neoantigen vaccine and pembrolizumab in advanced hepatocellular carcinoma: a phase 1/2 trial.","description":"Programmed cell death protein 1 (PD-1) inhibitors have modest efficacy as a monotherapy in hepatocellular carcinoma (HCC). A personalized therapeutic cancer vaccine (PTCV) may enhance responses to PD-1 inhibitors through the induction of tumor-specific immunity. We present results from a single-arm, open-label, phase 1/2 study of a DNA plasmid PTCV (GNOS-PV02) encoding up to 40 neoantigens coadministered with plasmid-encoded interleukin-12 plus pembrolizumab in patients with advanced HCC previously treated with a multityrosine kinase inhibitor. Safety and immunogenicity were assessed as primary endpoints, and treatment efficacy and feasibility were evaluated as secondary endpoints. The most common treatment-related adverse events were injection-site reactions, observed in 15 of 36 (41.6%) ","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Apr","modification":"2026-05-29T09:44:44.752Z","creation":"2025-07-27T03:11:09.063Z"},"accession":"S-EPMC11031401","cross_references":{"pubmed":["38584166"],"doi":["10.1038/s41591-024-02894-y"]}}