NCT05283109

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

ETAPA I: Evaluation of Tumor Associated P30-Peptide Antigen I; A Pilot Trial of Peptide-based Tumor Associated Antigen Vaccines in Newly Diagnosed, Unmethylated, and Untreated Glioblastoma (GBM)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Mustafa Khasraw, MBChB, MD, FRCP, FRACP · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 following primary objective: Evaluate the safety profile of a cancer vaccine comprised of P30-linked EphA2, CMV pp65, and survivin peptides. A maximum of 36 patients with a newly diagnosed, previously untreated WHO grade IV malignant glioma that is MGMT promoter unmethylated will be treated in this study after undergoing standard of care surgical resection followed by 6 weeks of radiation therapy (XRT) with concomitant temozolomide (TMZ) and providing informed consent. Patients will receive seven P30 linked-EphA2, -CMV pp65, and -survivin (P30-EPS) peptide vaccines over two phases. The first 5 will be given during the Priming Phase (day 1 through day 22). The final 2 will be given during the Booster Phase (day 84 \[± 2 days\] and day 140 \[± 2 days\]). During the Booster Phase on Day 84, patients will also be given 20ug/kg Hiltonol® injections to administer at home every 2 weeks until they return on Day 140. Blood will be drawn throughout the study to investigate the immune response to P30-EPS vaccination. The study will enroll two patient strata: patients who are CMV seronegative and patients who are CMV seropositive. Within each stratum, cohorts of 3 patients will initially be accrued to the study to assess the toxicity associated with the vaccine. The starting dose of P30-EPS is 300 μg/peptide/dose, and the dose will be escalated to 400 μg/peptide/dose. In the event of unacceptable dose-limiting toxicity, the dose will be de-escalated to 200 μg/peptide/dose (dose level minus one). Acute toxicity monitoring will focus on dose-limiting toxicities, as defined in Section 9.1.2 of the protocol, occurring between vaccine 1 and 30 days after vaccine 5. The most common side effects of peptide vaccines are redness or swelling at the injection site, local changes to the texture of your skin (hardening) at the injection site, itching, allergic reactions, and a potentially serious side effect called cytokine release syndrome. The most common side effects of Hiltonol® are reactions at the injection site and flu-like symptoms.

Conditions

• Glioma, Malignant

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-30
• Primary completion: 2025-04-11
• Completion: 2028-02-28
• First posted: 2022-03-16
• Last updated: 2025-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study