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New personalized Vaccine-Like therapy takes on deadly brain cancer

NCT ID NCT04485949

Disease control Sponsor: Imvax Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 3 times

Summary

This phase 2b trial tests IGV-001, a personalized immunotherapy made from each patient's own tumor cells, for newly diagnosed glioblastoma. About 93 participants receive either IGV-001 or a placebo, along with standard radiation and chemotherapy. The goal is to see if the treatment can delay tumor growth and improve survival.

What this could mean

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

Active substance
IGV-001 (personalized cell immunotherapy using the patient's own tumor cells combined with an antisense oligonucleotide)
What this could lead to
If successful, this could offer a new treatment option that slows glioblastoma progression and extends survival for newly diagnosed patients.
What could go wrong
This is a mid-stage trial with only 93 participants, so results may not apply to all patients. The treatment is complex and personalized, and side effects are still being studied.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

99 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 70 years

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.

Key Inclusion Criteria: * Has a Karnofsky performance scale (KPS) score ≥ 70 at screening * Has a new diagnosis of GBM (WHO GRADE III or Grade IV GBM) based on the treating neurosurgeon's best clinical judgement * Has a diagnostic contrast-enhanced magnetic resonance imaging (MRI) scan with fluid attenuated inversion-recovery (FLAIR) sequence of the brain at screening. Participants must have a confirmed measurable disease pre-operatively with at least 1 lesion measuring a total bi-perpendicular product of 4 centimeter square (cm\^2) in 2 different planes (axial, sagittal, or coronal) * The tumor must be located in the supratentorial compartment * Has adequate bone marrow and organ function at screening Key Exclusion Criteria: * Has bi-hemispheric disease, multicentric disease, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement * Has received any previous surgical resection or any anticancer intervention for glioma * Has any history of glioma, a concurrent malignancy, or malignancy within 3 years of randomization, unless definitive therapy is completed, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy * Has any severe immunocompromised condition (eg, human immunodeficiency virus (HIV) with a cluster of differentiation \[CD\] 4+ cell count \<200\*10\^6/liter \[L\]) or any active uncontrolled autoimmune disease (eg, Crohn's disease) * Has an active cardiac disease or a history of cardiac dysfunction * Is receiving any other investigational agent(s) or has received an investigational agent within 30 days or 5 half-lives of investigational agent use, whichever is longer, prior to screening * Is partaking in another interventional study. Participants who are partaking in an observational study are eligible * Has received a live vaccine within 30 days of screening * Has active and uncontrolled/untreated hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, or any other active infections that, in the Investigator's opinion, would impair or prohibit a participant's participation in this study. * Is receiving treatment with Tumor Treating Fields or Optune®

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Conditions

The condition(s) this trial relates to.

glioblastoma

As listed by the trial registrant

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

Glioblastoma

Contacts and locations

Locations

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • John Theurer Cancer Center At Hackensack UMC

    Hackensack, New Jersey, 07601, United States

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Northwell Health at North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • The Ohio State University (OSU) Wexner Medical Center

    Columbus, Ohio, 43201, United States

  • The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UC Health

    Cincinnati, Ohio, 45229, United States

  • University of North Carolina (UNC) - Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19130, United States

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53705, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

More trials for these conditions

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