NCT03223103

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

Active, enrolled Phase 1 Last updated 10 September 2025

What this trial tests

Phase 1 trial testing Poly-ICLC in Glioblastoma in 13 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 March 2018

Primary endpoint
12 May 2029

12 May 2029

Quick facts

Lead sponsor	Adilia Hormigo
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 March 2018
Primary completion	12 May 2029
Estimated completion	12 May 2029
Sites	1 location across United States

Drugs / interventions tested

• Poly-ICLC
• Tumor Treating Fields
• Peptides — full drug profile →

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

Adilia Hormigo

Who can join

18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glioblastoma in adults: a Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) consensus review on current management and future directions.
   Wen PY, Weller M, Lee EQ, Alexander BM, et al · · 2020 · cited 908× · PMID 32328653 · DOI 10.1093/neuonc/noaa106
2. Brain immunology and immunotherapy in brain tumours.
   Sampson JH, Gunn MD, Fecci PE, Ashley DM. · · 2020 · cited 525× · PMID 31806885 · DOI 10.1038/s41568-019-0224-7
3. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
4. Harnessing the immune system in glioblastoma.
   Brown NF, Carter TJ, Ottaviani D, Mulholland P. · · 2018 · cited 178× · PMID 30393372 · DOI 10.1038/s41416-018-0258-8
5. Treatment of Glioblastoma (GBM) with the Addition of Tumor-Treating Fields (TTF): A Review.
   Fabian D, Guillermo Prieto Eibl MDP, Alnahhas I, Sebastian N, et al · · 2019 · cited 163× · PMID 30717372 · DOI 10.3390/cancers11020174
6. Harnessing innate immune pathways for therapeutic advancement in cancer.
   Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
7. Neoantigen prediction and computational perspectives towards clinical benefit: recommendations from the ESMO Precision Medicine Working Group.
   De Mattos-Arruda L, Vazquez M, Finotello F, Lepore R, et al · · 2020 · cited 126× · PMID 32610166 · DOI 10.1016/j.annonc.2020.05.008
8. Trial watch: Peptide-based vaccines in anticancer therapy.
   Bezu L, Kepp O, Cerrato G, Pol J, et al · · 2018 · cited 114× · PMID 30524907 · DOI 10.1080/2162402x.2018.1511506