Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma

NCT03223103 | Active Not Recruiting Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: 2022-1381716-089
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use precision medicine in the form of a vaccine, a mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields). The study is designed to determine whether this treatment combination is well tolerated and safe.

Conditions

Glioblastoma

Keywords

Brain cancer; Glioblastoma; Personalized vaccine; Polyinosinic-polycytidylic acid (Poly-ICLC); Immunotherapy; Cancer; NovoTTF-200A; Optune; GBM; immunogenicity

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicities (DLT)

  Safety and Tolerability of the personalized treatment regimen will be assessed in tandem using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. NCI-CTCAE is a standard system for grading and reporting adverse events (AEs) in cancer clinical trials to document the occurrence and severity of AEs, with grades ranging from 1 (mild) to 5 (death). DLTs will be summarized and reported.

  long term, up to 10 years after treatment initiation

• Feasibility of Personalized MTA vaccine administration

  Feasibility of the personalized MTA vaccine will be defined as the successful administration of at least one (1) dose to subjects following tissue sample acquisition and will be expressed as the proportion or percentage subjects enrolled in the study who have successfully been administered at least one dose of the personalized MTA vaccine.

  Up to 42 weeks after treatment initiation

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  6 months after diagnosis

• Overall Survival (OS)

  1 year, 2 years, 5 years, and 10 years after diagnosis

Other Outcomes (1)

• Overall Response

  2 years after treatment initiation

Study Arms (1)

Mutation-derived tumor vaccine

EXPERIMENTAL

MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields

Drug: Poly-ICLC; Device: Tumor Treating Fields; Biological: Peptides

Interventions

Poly-ICLC DRUG

Poly-ICLC 100mcg per peptide per dose

Also known as: Hiltonol®

Mutation-derived tumor vaccine

Tumor Treating Fields DEVICE

an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM

Also known as: Optune®

Mutation-derived tumor vaccine

Peptides BIOLOGICAL

synthetic long peptides (SLP) as vaccine substrate

Also known as: Personalized peptides

Mutation-derived tumor vaccine

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• Histological confirmation of GBM (WHO grade IV).
• Stable disease after treatment of radiation with concurrent chemotherapy. If the disease is not stable or progresses while in the study the patient is allowed to continue the study receiving the vaccine if the tumor gets controlled by other modality treatment(s)
• Must have received maximal debulking surgery and undergo radiotherapy concomitant with Temozolomide (45-70Gy)
• Life expectancy \> 16 weeks
• Performance status of 0-2 as determined by Eastern Cooperative Oncology Group (ECOG) and/or Karnofsky Performance Status (KPS) 70-100
• First vaccine treatment start date at least 4 weeks out but not more than 8 weeks from the last dose of concomitant Temozolomide or radiotherapy
• Must have archival tumor tissue that is sufficient quantity and quality for sequencing
• Have adequate bone marrow function
• Requires Dexamethasone ≤ 4mg daily on a stable dose
• Acceptable hematologic, hepatic, and renal function and these tests must be performed within 14 days prior to study
• Must be deemed competent to give informed consent
• Must agree to use two effective forms of contraception beginning at least four (4) weeks prior to study entry, and continuing to do so for the duration of participation in the study

You may not qualify if:

• Progression of disease at time of screening
• Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
• Infra-tentorial tumor or multifocal disease
• History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to Decarbazine (DTIC)
• Receiving any other investigational agents. Patient is allowed to get another investigational agent and to continue receiving the vaccine only if the disease progresses while in the study and the other investigational agent is a reasonable choice to treat the patient
• Active cancer at the time of screening
• Prior history of unrelated neoplastic disease, and having received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluation.
• History of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), chronic hepatitis B or hepatitis C or is otherwise reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression
• History of, or is reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression; or the subject is currently receiving any drug or supplement which is known to be associated with systemic immune suppression including those drugs which are prescribed for solid organ or stem cell transplant, autoimmune/inflammatory disorders, or other related medical conditions
• History of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of: Vitiligo, diabetes, or thyroid dysfunction
• Less than 18 years of age, or otherwise unable to give informed consent due to minor status
• Prisoner, as defined by \[45 CFR 46.303(c)\]
• Cognitively impaired, and unable to give informed consent
• Pregnant, as defined by a presumptive sign of pregnancy such as missed menses or a positive pregnancy test \[45 CFR 46.203(b)\]
• Requires or is likely to require more than a 2-week course of corticosteroids of \>4mg

Sponsors & Collaborators

• Adilia Hormigo: lead
• NovoCure Ltd.: collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms; Neoplasms

Interventions

poly ICLC; Peptides

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Adilia Hormigo, MD, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 19, 2017
• Study Start: March 1, 2018
• Primary Completion (Estimated): May 12, 2029
• Study Completion (Estimated): May 12, 2029
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

US (1)