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GlioblastomaPhase 2NCT04485949

A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma

A Phase 2 study testing IGV-001 Cell Immunotherapy and SOC: Temozolomide in people with Glioblastoma, run by Imvax at 23 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to assess progression-free survival (PFS) and overall survival (OS) in newly diagnosed Glioblastoma (GBM) participants treated with IGV-001 as compared with placebo. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Glioblastoma
What is being tested?
IGV-001 Cell Immunotherapy and SOC: Temozolomide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
23 sitesUnited States
Study dates
20 Mar 2023to Jul 2027
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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®

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • University of North Carolina (UNC) - Chapel Hill

    Chapel Hill, North Carolina, 27599

  • UC Health

    Cincinnati, Ohio, 45229

  • The Ohio State University (OSU) Wexner Medical Center

    Columbus, Ohio, 43201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • John Theurer Cancer Center At Hackensack UMC

    Hackensack, New Jersey, 07601

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

    Hershey, Pennsylvania, 17033

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53705

  • Northwell Health at North Shore University Hospital

    Manhasset, New York, 11030

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

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

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Weill Cornell Medicine

    New York, New York, 10065

  • Lenox Hill Hospital

    New York, New York, 10075

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19130

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Westchester Medical Center

    Valhalla, New York, 10595

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF-1R, in Newly Diagnosed Patients With Glioblastoma

The purpose of this study is to assess progression-free survival (PFS) and overall survival (OS) in newly diagnosed Glioblastoma (GBM) participants treated with IGV-001 as compared with placebo.

Conditions
Glioblastoma
Being tested
IGV-001 Cell Immunotherapy, Placebo, Standard of Care (SOC): Radiation Therapy, SOC: Temozolomide
Keywords
Newly Diagnosed
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IGV-001 Cell ImmunotherapyCombination product

    IGV-001, an immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers.

  • PlaceboCombination product

    Placebo in implantable biodiffusion chambers containing a predetermined inactive solution.

  • Standard of Care (SOC): Radiation TherapyProcedure or surgery

    Radiation therapy administered per institutional standards.

  • SOC: TemozolomideDrug

    Temozolomide administered orally.

Study groups in NCT04485949
Study groupRoleWhat they receive
IGV-001ExperimentalParticipants will be implanted with biodiffusion chambers containing IGV-001 on Day 1 and explanted on Day 3 (at approximately 48 hours following implantation). After 6 weeks, participants will receive radiotherapy (RT) per institutional standards for 5 days per week along with temozolomide 75 mg/m^2 orally, once daily (QD) for up to 12 weeks followed by temozolomide 150 to 200 mg/m^2, orally, on Days 1 to 5 of each 28-day cycle for up to 6 cycles (Week 41).
Receives: Combination Product: IGV-001 Cell Immunotherapy; Procedure: Standard of Care (SOC): Radiation Therapy; Drug: SOC: Temozolomide
PlaceboPlacebo comparatorParticipants will be implanted with biodiffusion chambers containing placebo on Day 1 and explanted on Day 3 (at approximately 48 hours following implantation). After 6 weeks, participants will receive RT per institutional standards for 5 days per week along with temozolomide 75 mg/m^2 orally, QD for up to 12 weeks followed by temozolomide 150 to 200 mg/m^2, orally, on Days 1 to 5 of each 28-day cycle for up to 6 cycles (Week 41).
Receives: Combination Product: Placebo; Procedure: Standard of Care (SOC): Radiation Therapy; Drug: SOC: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    PFS is defined as the time from randomization to first progression, as determined by the central radiology review group blinded to the study treatment arm, or death.

    Measured: Up to 36 months

Secondary outcomes (5)

  1. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to 48 months

  2. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Events (ADE), and Unexpected Adverse Device Events (ADR)

    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a product, which does not have a causal relationship with treatment. AEs will be graded according to Common Terminology Criteria for Adverse Events, version 5.0 from mild(Grade 1) to death(Grade 5). SAE is an AE which is considered serious if it results in any of the following outcomes: death, life-threatening AE, require hospitalizations/prolongation of hospitalizations, results in persistent or significant disability; results in a congenital anomaly and is a medically important event. An ADE is defined as any AE caused by or associated with use of a device and suspected to be resulting from insufficiencies in the instructions for use, the deployment, the implantation, the installation, the operation, or any malfunction of the medical device. An Unexpected ADR is defined as an adverse reaction, nature or severity of which is not consistent with product information.

    Measured: Up to 36 months

  3. Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

    Measured: Up to 36 months

  4. Number of Participants With Clinically Significant Vital Signs Measurements

    Measured: Up to 36 months

  5. Number of Participants With Clinically Significant Physical Examination Findings

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2020
  2. Study start20 Mar 2023
  3. Primary completionJan 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04485949
Sponsor's protocol ID
14379-201
Status last verified
Jul 2026
First submitted
22 Jul 2020
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Lee IY, Hanft S, Schulder M, Judy KD, Wong ET, Elder JB, Evans LT, Zuccarello M, Wu J, Aulakh S, Agarwal V, Ramakrishna R, Gill BJ, Quinones-Hinojosa A, Brennan C, Zacharia BE, Silva Correia CE, Diwanji M, Pennock GK, Scott C, Perez-Olle R, Andrews DW, Boockvar JA. Autologous cell immunotherapy (IGV-001) with IGF-1R antisense oligonucleotide in newly diagnosed glioblastoma patients. Future Oncol. 2024 Mar;20(10):579-591. doi: 10.2217/fon-2023-0702. Epub 2023 Dec 7.

    PubMed 38060340

  • Andrews CE, Zilberberg J, Perez-Olle R, Exley MA, Andrews DW. Targeted immunotherapy for glioblastoma involving whole tumor-derived autologous cells in the upfront setting after craniotomy. J Neurooncol. 2023 Dec;165(3):389-398. doi: 10.1007/s11060-023-04491-4. Epub 2023 Nov 29.

    PubMed 38017340

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IGV-001 Cell Immunotherapy and SOC: Temozolomide in people with Glioblastoma, run by Imvax at 23 sites 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 5 inclusion and 10 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Progression-free Survival (PFS) (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04485949, which also lists 2 linked publications.

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 9 Jul 2026.

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