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Brain cancer vaccine trial combines custom peptides with electric fields

NCT ID NCT03223103

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 21, 2026 · Updated 2 times

Summary

This early-phase trial tests whether a personalized vaccine made from each patient's tumor mutations, combined with Tumor Treating Fields (a device that sends electric fields to the brain), is safe and feasible for people with newly diagnosed glioblastoma. The 13 participants receive the vaccine alongside standard care. The main goals are to check for side effects and see if the vaccine can be successfully made and given.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
personalized mutation-derived tumor vaccine (peptides) plus Poly-ICLC (Hiltonol) and Tumor Treating Fields (Optune device)
What this could lead to
If successful, this could point toward a new way to treat glioblastoma by combining a personalized vaccine with standard care to help the immune system target the tumor.
What could go wrong
This is a very early (Phase 1) and small (13 people) trial focused on safety, not effectiveness. The vaccine is custom-made for each patient, which is complex and may not work for everyone. There is also a risk of side effects from the vaccine or device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

Mar 2018

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.