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

NCT05283109 | Active Not Recruiting Phase 1 Results DMC FDA Drug

• 2 other identifiers: Pro001028185P50CA190991
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma, Malignant

Keywords

ETAPA; Pro00102818; Khasraw; Glioblastoma; Glioma; Duke; Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Dose-limiting Toxicity (DLT)

  A dose-limiting toxicity (DLT) is as an unacceptable toxicity, based on CTCAE v5.0, that occurs during the DLT observation period that extends between date of vaccine #1 (Day 1) and 30 days after vaccine #5 (Day 22). Any ≥ Grade 3 AEs were to be considered as unacceptable toxicities if they were possibly, probably, or definitely attributable to the protocol treatment regimen, and if they occurred within 30 days of vaccination. Specifically, any ≥ Grade 3 organ toxicity (cardiac, renal, hepatic), including CRS-related toxicities such as hypotension and tachycardia, of any duration was to be considered an unacceptable toxicity. A Grade 3 neurologic toxicity was only to be declared an unacceptable toxicity if not reversible within 48 hours. Grade 3 flu-like symptoms, fever, and chills/rigors were not considered unacceptable if the duration was less than 72 hours.

  Approximately 2 months after initiation of P30-EPS study vaccine

Secondary Outcomes (6)

• Change in Mean Fold Increase in pp56-specific T Cells; Time Frame: Day 1, 22, 84

  3 months

• Change in Mean Fold Increase in EphA2- or Survivin- Specific T Cells; Time Frame: Days 1, 22, 84

  3 Months

• Change in Mean Fold Increase in pp56-specific T Cells; Time Frame: Day 1, 22, 84

  5 months

• Change in Mean Fold Increase in EphA2- or Survivin- Specific T Cells; Time Frame: Days 1, 22, 84

  5 months

• Median Survival

  36 months

Study Arms (1)

Tumor Associated Antigen Peptide Vaccine in Combination with Hiltonol

EXPERIMENTAL

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.

Biological: Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine; Drug: Hiltonol

Interventions

Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine BIOLOGICAL

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

Also known as: P30-EPS

Tumor Associated Antigen Peptide Vaccine in Combination with Hiltonol

Hiltonol DRUG

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.

Also known as: poly-ICLC

Tumor Associated Antigen Peptide Vaccine in Combination with Hiltonol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years of age
• Newly diagnosed Isocitrate dehydrogenase (IDH) wild type (CARIS result), MGMT promoter unmethylated (CARIS result) WHO grade IV glioma (e.g., glioblastoma (GBM) or high grade glioma with molecular features of GBM) with definitive resection prior to enrollment, and residual radiographic contrast enhancement on immediate post-surgical computed tomography (CT), or magnetic resonance imaging (MRI).
• CMV positive or negative by IgG testing.
• Karnofsky Performance Status (KPS) of \> 70%.
• Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,000 cells/µl, platelets ≥ 100,000 cells/µl.
• Serum creatinine ≤ 3 x the upper limit of normal (ULN), serum glutamic oxaloacetic transaminase (SGOT)≤ 3 times ULN
• Bilirubin ≤ 1.5 times ULN (Exception: Patient has known Gilbert's Syndrome or patient has suspected Gilbert's Syndrome, for which additional lab testing of direct and/or indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)
• Signed informed consent approved by the Institutional Review Board.
• Female patients must not be pregnant or breast-feeding. Female patients of childbearing potential (defined as \< 2 years after last menstruation or not surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control, \[i.e. with a failure rate of \< 1% per year\] are implants, injectables, combined oral contraceptives, intra-uterine device \[IUD; only hormonal\], sexual abstinence or vasectomized partner) during the trial and for a period of \> 6 months following the last administration of trial drug(s). Female patients with an intact uterus (unless amenorrhea for the last 24 months) must have a negative serum pregnancy test within 48 hours prior to first vaccination.
• Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control \[i.e. with a failure rate of \< 1% per year\] include a female partner using implants, injectables, combined oral contraceptives, IUDs \[only hormonal\], sexual abstinence or prior vasectomy) during the trial and for a period of \> 6 months following the last administration of trial drug(s).

You may not qualify if:

• Patients with known potentially anaphylactic allergic reactions to gadolinium-diethylenetriaminepentaacetic acid (DTPA), or any component of the tetanus-diphtheria vaccine.
• Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, radiological evidence of multifocal disease, or leptomeningeal disease.
• Areas of high-grade glioma outside the original radiation field on the post XRT/TMZ MRI.
• Patients who cannot undergo MRI.
• Severe, active comorbidity, including any of the following:
• Unstable angina and/or congestive heart failure requiring hospitalization;
• Transmural myocardial infarction within the last 6 months;
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of first -vaccination;
• Active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax \> 99.5°F/37.5°C)
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy;
• Known hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
• Known immunosuppressive disease or Human Immunodeficiency Virus (HIV) and -Hepatitis C positive status;
• Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy;
• Active connective tissue disorders, such as lupus or scleroderma that, in the opinion of the treating physician, may put the patient at high risk for radiation toxicity.
• Co-medication that may interfere with study results (e.g., immuno-suppressive agents other than corticosteroids).

Sponsors & Collaborators

• Mustafa Khasraw, MBChB, MD, FRCP, FRACP: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The Preston Robert Tisch Brain Tumor Center at Duke University

Durham, North Carolina, 27710, United States

Location

Related Links

• The Preston Robert Tisch Brain Center at Duke University
• Duke Health

MeSH Terms

Conditions

Glioma; Glioblastoma

Interventions

poly ICLC

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Results Point of Contact

• Title: Evan D. Buckley, MB
• Organization: Duke University

evan.buckley@duke.edu

(919) 681-5048

Study Officials

• Mustafa Khasraw, MBChB, MD, FRCP, FRACP

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurosurgery

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 16, 2022
• Study Start: August 30, 2023
• Primary Completion: April 11, 2025
• Study Completion (Estimated): February 28, 2028
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)