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ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM

NCT05283109 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-30

Study results available
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Summary

This is a phase 1b study of P30-linked EphA2, CMV pp65, and survivin vaccination (collectively called the P30-EPS vaccine) in HLA-A\*0201 positive patients with a newly diagnosed, unmethylated, and untreated World Health Organization (WHO) grade IV malignant glioma.

Conditions

  • Glioma, Malignant

Interventions

BIOLOGICAL

Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine

Vaccine that includes 3 peptides (EphA2 linked to P30 peptide, pp65 linked to P30 peptide, and Survivin linked to P30 peptide)

DRUG

Hiltonol

Hiltonol® is made up of synthetic (manmade) RNA (ribonucleic acid) and is used as an adjuvant to the vaccine, meaning it is used with the vaccine to stimulate or enhance the activation of your immune system.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mustafa Khasraw, MBChB, MD, FRCP, FRACP

    lead OTHER

Principal Investigators

  • Mustafa Khasraw, MBChB, MD, FRCP, FRACP · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-30
Primary Completion
2025-04-11
Completion
2028-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05283109 on ClinicalTrials.gov