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

NCT03223103 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-09-10

No results posted yet for this study

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

Interventions

DRUG

Poly-ICLC

Poly-ICLC 100mcg per peptide per dose

DEVICE

Tumor Treating Fields

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

BIOLOGICAL

Peptides

synthetic long peptides (SLP) as vaccine substrate

Sponsors & Collaborators

  • NovoCure Ltd.

    collaborator INDUSTRY
  • Adilia Hormigo

    lead OTHER

Principal Investigators

  • Adilia Hormigo, MD, PhD · Albert Einstein College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2029-05-12
Completion
2029-05-12
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03223103 on ClinicalTrials.gov