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

Phase 1

Recruiting

• Conditions: Glioma, Malignant
• Interventions: Biological: Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine; Drug: Hiltonol

• Registration Number: NCT05283109
• Lead Sponsor: Mustafa Khasraw, MBChB, MD, FRCP, FRACP

Brief 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.

Detailed Description

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 at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke, is planned to address the fol...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-16
• Study Start: 2023-08-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2025-04
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor Associated Antigen Peptide Vaccine in Combination with Hiltonol	Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine	The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin.
Tumor Associated Antigen Peptide Vaccine in Combination with Hiltonol	Hiltonol	The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin.

Primary Outcome Measures

Name	Time	Method
Percentage of patients who experience dose-limiting toxicity	2 months	Percentage of patients who experience dose-limiting toxicity within each stratum at each dose level

Secondary Outcome Measures

Name	Time	Method
Change in mean fold increase in pp56-specific T cells; Time Frame: Day 1, 22, 84	5 months	Stratified between CMV seropositive and seronegative patients
Median survival	36 months	Amongst all patients
Change in mean fold increase in EphA2- or survivin- specific T cells; Time Frame: Days 1, 22, 84	5 months	Amongst all patients
Median progression-free survival	36 months	Amongst all patients

Trial Locations

Locations (1)

The Preston Robert Tisch Brain Tumor Center at Duke University; 🇺🇸 Durham, North Carolina, United States