Evidence map›Paper›PMID 38584166›Full record

Trial reportNature medicine2024

Personalized neoantigen vaccine and pembrolizumab in advanced hepatocellular carcinoma: a phase 1/2 trial.

Mark Yarchoan, Edward J Gane, Thomas U Marron, Renzo Perales-Linares, Jian Yan, Neil Cooch, Daniel H Shu, Elana J Fertig, Luciane T Kagohara, Gabor Bartha and 10 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in Nature medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04251117 (An Open-label, Multi-center, Phase I/IIa Study of a Personalized Neoantigen DNA Vaccine), which is not on this map. Cited by 187 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
187citing papers in PubMed, 1 pooled it
53.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT04251117 phase1 / phase2active not recruitingnot on this map

An Open-label, Multi-center, Phase I/IIa Study of a Personalized Neoantigen DNA Vaccine (GNOS-PV02) and Plasmid Encoded IL-12 (INO-9012) in Combination With Pembrolizumab (MK-3475) in Subjects With Advanced Hepatocellular Carcinoma

TypeinterventionalSponsorGeneos TherapeuticsRan2020 to 2028Enrolled36ConditionsHCCArmsGNOS-PV02, INO-9012, Pembrolizumab, CELLECTRA®2000 EP Device
3 · Its place in the literature

Who cites it

187 citing papers in PubMed, 1 synthesis or guideline pooled it, 189 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Development of mRNA vaccines against herpes zoster.Human vaccines & immunotherapeutics · 2026
    Review
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  9. Review
  10. Article
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  12. Personalized neoantigen mRNA vaccines for pancreatic cancer: the role of lipid nanoparticle delivery systems.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026
    Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
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  20. Overcoming Drug Resistance by Paclitaxel Resistance in Triple-Negative Breast Cancer.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Article

127 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 8 institutions in 2 countries.

Mark YarchoanDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. mark.yarchoan@jhmi.edu.ORCID 0000-0003-4401-0748
Edward J GaneNew Zealand Liver Transplant Unit, University of Auckland, Auckland, New Zealand.
Thomas U MarronEarly Phase Trials Unit, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0001-5903-8191
Renzo Perales-LinaresGeneos Therapeutics, Philadelphia, PA, USA.
Jian YanGeneos Therapeutics, Philadelphia, PA, USA.ORCID 0009-0007-8781-2544
Neil CoochGeneos Therapeutics, Philadelphia, PA, USA.
Daniel H ShuDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Elana J FertigDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0003-3204-342X
Luciane T KagoharaDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0003-1706-0950
Gabor BarthaPersonalis, Inc., Fremont, CA, USA.
Josette NorthcottPersonalis, Inc., Fremont, CA, USA.
John LylePersonalis, Inc., Fremont, CA, USA.
Sarah RochestieGeneos Therapeutics, Philadelphia, PA, USA.
Joann PetersGeneos Therapeutics, Philadelphia, PA, USA.
Jason T ConnorConfluenceStat, Cooper City, FL, USA.
Elizabeth M JaffeeDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0003-3841-6549
Ildiko CsikiGeneos Therapeutics, Philadelphia, PA, USA.
David B WeinerVaccine and Immunotherapy Center, The Wistar Institute, Philadelphia, PA, USA.ORCID 0000-0002-2232-8512
Alfredo Perales-PuchaltGeneos Therapeutics, Philadelphia, PA, USA.ORCID 0000-0003-4904-5050
Niranjan Y SardesaiGeneos Therapeutics, Philadelphia, PA, USA. sardesai@geneostx.com.ORCID 0000-0001-6920-1167
Io Therapeutics (United States) · USJohns Hopkins University · USPersonalis (United States) · USGenex Systems (United States) · USIcahn School of Medicine at Mount Sinai · USThe Wistar Institute · USUniversity of Auckland · NZUniversity of Central Florida · US

Funding

Tumor Microenvironment and MetastasisP30CA010815 · NCI · WISTAR INSTITUTE · PI Luis J Montaner · 1985 to 2026
$75.9M
Integrating bioinformatics into multiscale models for hepatocellular carcinomaU01CA212007 · NCI · JOHNS HOPKINS UNIVERSITY · PI EWALD, ANDREW JOSEF, FERTIG, ELANA · 2018 to 2022
$3.2M
Neoadjuvant Immunotherapy Platform Study Reveals Mechanisms of Response in Hepatocellular Carcinoma (HCC)R01CA285544 · NCI · JOHNS HOPKINS UNIVERSITY · PI Won Jin Ho, Mark Yarchoan · 2024 to 2026
$2.0M
NCI NIH HHS P30 CA010815NCI NIH HHS R01 CA285544NCI NIH HHS U01 CA212007
6 · The paper itself

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%) patients. No dose-limiting toxicities or treatment-related grade ≥3 events were observed. The objective response rate (modified intention-to-treat) per Response Evaluation Criteria in Solid Tumors 1.1 was 30.6% (11 of 36 patients), with 8.3% (3 of 36) of patients achieving a complete response. Clinical responses were associated with the number of neoantigens encoded in the vaccine. Neoantigen-specific T cell responses were confirmed in 19 of 22 (86.4%) evaluable patients by enzyme-linked immunosorbent spot assays. Multiparametric cellular profiling revealed active, proliferative and cytolytic vaccine-specific CD4

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsVaccinesAntibodies, Monoclonal, HumanizedHumansAntibodies, Monoclonal, HumanizedpembrolizumabVaccines

Identifiers

PMID38584166
PMCPMC11031401
OpenAlexW4394063358

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.