GlioblastomaPhase 1NCT03223103
Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
A Phase 1 study testing Poly-ICLC, Tumor Treating Fields and Peptides in people with Glioblastoma, run by Adilia Hormigo at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Poly-ICLC, Tumor Treating Fields and Peptides
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 12 May 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients With Newly Diagnosed Glioblastoma (GCO 17-0566)
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.
Read the detailed description
This is a single-arm, single institution phase 1a / 1b study to test the safety, tolerability, and immunogenicity of MTA-based personalized vaccine in patients with newly diagnosed GBM along with the use of continual TTFields. MTA-based personalized vaccine is prepared in the laboratory with several peptides based on each patient's own tumor sequence.
The vaccine is given after the radiation and chemotherapy portion of the treatment, in the maintenance phase of temozolomide in conjunction with the TTFields.
- Conditions
- Glioblastoma
- Being tested
- Poly-ICLC, Tumor Treating Fields, Peptides
- Keywords
- Brain cancer, Glioblastoma, Personalized vaccine, Polyinosinic-polycytidylic acid (Poly-ICLC), Immunotherapy, Cancer, NovoTTF-200A, Optune, GBM, immunogenicity
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-ICLCDrug
Also called Hiltonol®
Poly-ICLC 100mcg per peptide per dose
Tumor Treating FieldsDevice
Also called Optune®
an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM
PeptidesBiological
Also called Personalized peptides
synthetic long peptides (SLP) as vaccine substrate
| Study group | Role | What they receive |
|---|---|---|
| Mutation-derived tumor vaccine | Experimental | MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields Receives: Drug: Poly-ICLC; Device: Tumor Treating Fields; Biological: Peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 42 weeks after treatment initiation
Secondary outcomes (2)
Progression Free Survival (PFS)
PFS will be determined by the percentage of patients whose disease remains stable, without disease progression or death, from the time diagnosis until 6 months after diagnosis.
Measured: 6 months after diagnosis
Overall Survival (OS)
Overall Survival will be determined by from the time of diagnosis to the time of death, or up to 10 years. OS will be summarized as the percentage of patients who reach the 1-year, 2-year, 5-year, and 10-year milestones.
Measured: 1 year, 2 years, 5 years, and 10 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Mar 2018
- Primary completion12 May 2029 (estimated)
- Study completion12 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adilia Hormigo
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd., Oncovir, Inc.
- Responsible party
- Sponsor-investigator, Adilia Hormigo, Albert Einstein College of Medicine
- Investigators
- Adilia Hormigo, MD, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223103
- Sponsor's protocol ID
- 2022-13817
- Other IDs
- 16-089
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2017
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients With Newly Diagnosed Glioblastoma (GCO 17-0566)
- ClinicalTrials.gov ID
- NCT03223103
- Acronym / sponsor ID
- 2022-13817
- Conditions
- Glioblastoma
- Keywords
- Brain cancer, Glioblastoma, Personalized vaccine, Polyinosinic-polycytidylic acid (Poly-ICLC), Immunotherapy, Cancer, NovoTTF-200A, Optune
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Adilia HormigoUniversity, hospital or other
- Collaborators
- NovoCure Ltd., Oncovir, Inc.
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 12 May 2029 (estimated)
- Study completion
- 12 May 2029 (estimated)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-arm, single institution phase 1a / 1b study to test the safety, tolerability, and immunogenicity of MTA-based personalized vaccine in patients with newly diagnosed GBM along with the use of continual TTFields. MTA-based personalized vaccine is prepared in the laboratory with several peptides based on each patient's own tumor sequence.
The vaccine is given after the radiation and chemotherapy portion of the treatment, in the maintenance phase of temozolomide in conjunction with the TTFields.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mutation-derived tumor vaccine | Experimental | Drug: Poly-ICLC, Device: Tumor Treating Fields, Biological: PeptidesMTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poly-ICLCAlso: Hiltonol®Poly-ICLC 100mcg per peptide per dose | Drug | Mutation-derived tumor vaccine |
| Tumor Treating FieldsAlso: Optune®an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM | Device | Mutation-derived tumor vaccine |
| PeptidesAlso: Personalized peptidessynthetic long peptides (SLP) as vaccine substrate | Biological | Mutation-derived tumor vaccine |
Primary outcome
Dose-limiting toxicities (DLT)
Time frame: long term, up to 10 years after treatment initiation
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.
Feasibility of Personalized MTA vaccine administration
Time frame: Up to 42 weeks after treatment initiation
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.
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: 6 months after diagnosis
Overall Survival (OS)
Time frame: 1 year, 2 years, 5 years, and 10 years after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adilia Hormigo, MD, PhD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Poly-ICLC, Tumor Treating Fields and Peptides in people with Glioblastoma, run by Adilia Hormigo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLT) (time frame: long term, up to 10 years after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.