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

Last updated: February 9, 2026
Sponsor: Imvax
Overall Status: Active - Not Recruiting

Phase

2

Condition

Gliomas

Astrocytoma

Treatment

Standard of Care (SOC): Radiation Therapy

IGV-001 Cell Immunotherapy

SOC: Temozolomide

Clinical Study ID

NCT04485949
14379-201
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 treatingneurosurgeon's best clinical judgement

  • Has a diagnostic contrast-enhanced magnetic resonance imaging (MRI) scan with fluidattenuated 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

Exclusion

Key Exclusion Criteria:

  • Has bi-hemispheric disease, multicentric disease, or disease burden involving thebrain stem or cerebellum based on MRI post-gadolinium enhancement

  • Has received any previous surgical resection or any anticancer intervention forglioma

  • Has any history of glioma, a concurrent malignancy, or malignancy within 3 years ofrandomization, unless definitive therapy is completed, with the exception of basalor squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ ofthe 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 anyactive 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 investigationalagent within 30 days or 5 half-lives of investigational agent use, whichever islonger, prior to screening

  • Is partaking in another interventional study. Participants who are partaking in anobservational 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®

Study Design

Total Participants: 93
Treatment Group(s): 4
Primary Treatment: Standard of Care (SOC): Radiation Therapy
Phase: 2
Study Start date:
March 20, 2023
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • ChristianaCare Helen F. Graham Cancer Center and Research Institute

    Newark, Delaware 19713
    United States

    Site Not Available

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Mayo Clinic - Jacksonville

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • Piedmont Healthcare

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • The University of Chicago Medical Center (UCMC)

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Tufts Medical Center

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Site Not Available

  • John Theurer Cancer Center At Hackensack UMC

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • John Theurer Cancer Center At Hackensack UMC

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune City 5101687, New Jersey 5101760 07753
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Northwell Health at North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

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

    New York, New York 10021
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Site Not Available

  • Westchester Medical Center

    Valhalla, New York 10595
    United States

    Site Not Available

  • Northwell Health at North Shore University Hospital

    Manhasset 5125766, New York 5128638 11030
    United States

    Site Not Available

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

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

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York 5128581, New York 5128638 10075
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10467
    United States

    Site Not Available

  • Westchester Medical Center

    Valhalla 5142090, New York 5128638 10595
    United States

    Site Not Available

  • University of North Carolina (UNC) - Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Wake Forest

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University of North Carolina (UNC) - Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • UC Health

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University (OSU) Wexner Medical Center

    Columbus, Ohio 43201
    United States

    Site Not Available

  • UC Health

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Site Not Available

  • The Ohio State University (OSU) Wexner Medical Center

    Columbus 4509177, Ohio 5165418 43201
    United States

    Site Not Available

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

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19130
    United States

    Site Not Available

  • Investigation Site

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

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

    Hershey 5193342, Pennsylvania 6254927 17033
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19130
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Site Not Available

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • West Virginia University

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Site Not Available

  • University of Wisconsin - Madison

    Madison, Wisconsin 53705
    United States

    Site Not Available

  • University of Wisconsin - Madison

    Madison 5261457, Wisconsin 5279468 53705
    United States

    Site Not Available

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