Evidence map›Paper›PMID 40506525›Full record

ArticleNature cancer2025

A peptide vaccine targeting the CMV antigen pp65 in children and young adults with recurrent high-grade glioma and medulloblastoma: a phase 1 trial.

Eric M Thompson, David M Ashley, Katayoun Ayasoufi, Pamela Norberg, Gerald Archer, Evan D Buckley, James E Herndon, Ashley Walter, Bridget Archambault, Charlene Flahiff and 19 more

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Nature cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03299309 (The PRiME Study), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT03299309 phase1active not recruitingnot on this map

The PRiME Study: PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

TypeinterventionalSponsorDaniel LandiRan2018 to 2027Enrolled30ConditionsRecurrent Medulloblastoma, Recurrent Brain Tumor, Childhood, Malignant GliomaArmsPEP-CMV
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  6. Cancer viroimmunotherapy platforms based on varicella-zoster virus and cytomegalovirus.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
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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

29 authors.

Eric M ThompsonDepartment of Neurological Surgery, Duke University, Durham, NC, USA. t.eric@wustl.edu.ORCID http://orcid.org/0000-0003-2796-9914
David M AshleyDepartment of Neurological Surgery, Duke University, Durham, NC, USA.ORCID http://orcid.org/0000-0002-4754-5900
Katayoun AyasoufiDepartment of Neurological Surgery, Duke University, Durham, NC, USA.
Pamela NorbergDepartment of Neurological Surgery, Duke University, Durham, NC, USA.
Gerald ArcherDepartment of Neurological Surgery, Duke University, Durham, NC, USA.
Evan D BuckleyDuke Cancer Institute Biostatistics, Duke University, Durham, NC, USA.
James E HerndonDepartment of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.
Ashley WalterPreston Robert Tisch Brain Tumor Center, Duke University, Durham, NC, USA.
Bridget ArchambaultDepartment of Pediatrics, Duke University, Durham, NC, USA.
Charlene FlahiffPreston Robert Tisch Brain Tumor Center, Duke University, Durham, NC, USA.
Denise JaggersPreston Robert Tisch Brain Tumor Center, Duke University, Durham, NC, USA.
Laura GorskiPreston Robert Tisch Brain Tumor Center, Duke University, Durham, NC, USA.ORCID http://orcid.org/0009-0001-9346-2997
Luis A SanchezDepartment of Neurological Surgery, Duke University, Durham, NC, USA.
Kendra CongdonDepartment of Neurological Surgery, Duke University, Durham, NC, USA.
Kelly HotchkissDepartment of Neurological Surgery, Duke University, Durham, NC, USA.
Sarah L CookDepartment of Neurological Surgery, Duke University, Durham, NC, USA.ORCID http://orcid.org/0000-0002-0516-9388
Eliese MoelkerDepartment of Neurological Surgery, Duke University, Durham, NC, USA.
Gordana VlahovicPreston Robert Tisch Brain Tumor Center, Duke University, Durham, NC, USA.
Elizabeth ReapDepartment of Neurological Surgery, Duke University, Durham, NC, USA.
Kristin SchroederPreston Robert Tisch Brain Tumor Center, Duke University, Durham, NC, USA.
Dina RandazzoDepartment of Neurological Surgery, Duke University, Durham, NC, USA.
Annick DesjardinsDepartment of Neurological Surgery, Duke University, Durham, NC, USA.ORCID http://orcid.org/0000-0003-3869-8283
Margaret O JohnsonDepartment of Neurological Surgery, Duke University, Durham, NC, USA.ORCID http://orcid.org/0000-0003-1208-622X
Katherine PetersDepartment of Neurological Surgery, Duke University, Durham, NC, USA.
Mustafa KhasrawDepartment of Neurological Surgery, Duke University, Durham, NC, USA.ORCID http://orcid.org/0000-0003-3249-9849
Henry FriedmanDepartment of Neurological Surgery, Duke University, Durham, NC, USA.ORCID http://orcid.org/0000-0001-7588-032X
Duane A MitchellDepartment of Neurological Surgery, The University of Florida, Gainesville, FL, USA.ORCID http://orcid.org/0000-0001-6049-213X
John H SampsonDepartment of Neurological Surgery, Duke University, Durham, NC, USA.
Daniel LandiPreston Robert Tisch Brain Tumor Center, Duke University, Durham, NC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The human cytomegalovirus (CMV) antigen pp65 is expressed in high-grade glioma (HGG) and medulloblastoma but not in the adjacent brain. This single-arm phase 1 trial ( NCT03299309 ) assessed the safety and immunogenicity of a peptide vaccine (PEP-CMV) targeting pp65 in individuals (3-35 years old) with recurrent HGG or medulloblastoma. Thirty-six individuals with HGG received PEP-CMV. The mean age was 22.75 ± 9.34 years. The primary outcome, percentage of unacceptable toxicity, was met. The maximum-grade adverse events (AE) related to PEP-CMV were 17 grade 1 AEs, 15 grade 2 AEs, 1 grade 3 AE (pyramidal tract syndrome) and 1 grade 4 AE (cerebral edema). As a secondary outcome, in 21 individuals with evaluable data, T cell reactivity, measured as change in baseline interferon-γ pp65 enzyme-linked immunospot assay reactivity, had an estimated increase of 46 spots (95% confidence interval (95% CI): 8, 194) after treatment with PEP-CMV. As exploratory endpoints, the median progression-free survival was 2.5 months (95% CI: 2.2, 3.2), and median overall survival was 6.5 months (95% CI: 4.6, 8.4). PEP-CMV is well tolerated and elicits an antigen-specific immune response in individuals with multiply recurrent HGG. Only two individuals with medulloblastoma were enrolled, showing one grade 3 encephalopathy possibly related to PEP-CMV, while neither had postvaccine immune assessments due to progression-free survival and overall survival less than 2 months.

Indexed as

Brain NeoplasmsCancer VaccinesGliomaMedulloblastomaViral Matrix ProteinsAdolescentAdultChildChild, PreschoolCytomegalovirusFemaleHumansMaleNeoplasm Recurrence, LocalPhosphoproteinsProtein Subunit VaccinesCancer Vaccinescytomegalovirus matrix protein 65kDaPhosphoproteinsProtein Subunit VaccinesVaccines, SubunitViral Matrix Proteins

Identifiers

PMID40506525

What OpenQuestion holds

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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.