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
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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