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NCT04485949Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 9 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
99 (actual)
First submitted
22 Jul 2020
Start date
20 Mar 2023
Primary completion date
Jan 2027
Lead sponsor
Imvax
Diseases
Glioblastoma
NCT number
NCT04485949

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 99
  • From 20 Mar 2023 to the primary completion date, Jan 2027
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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
  • Has received a live vaccine within 30 days of screening
  • Is receiving treatment with Tumor Treating Fields or Optune®

Other illness

  • Has bi-hemispheric disease, multicentric disease, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement
  • Has an active cardiac disease or a history of cardiac dysfunction
  • 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.

Lab values

  • 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)

Other

  • Is partaking in another interventional study. Participants who are partaking in an observational study are eligible

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tufts Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
University of North Carolina (UNC) - Chapel Hill
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Chapel HillUnited StatesUnknown status
UC Health
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CincinnatiUnited StatesUnknown status
The Ohio State University (OSU) Wexner Medical Center
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ColumbusUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
John Theurer Cancer Center At Hackensack UMC
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HackensackUnited StatesUnknown status
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
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HersheyUnited StatesUnknown status
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
University of Wisconsin - Madison
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MadisonUnited StatesUnknown status
Northwell Health at North Shore University Hospital
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ManhassetUnited StatesUnknown status
West Virginia University
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MorgantownUnited StatesUnknown status
Jersey Shore University Medical Center
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Neptune CityUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Lenox Hill Hospital
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New YorkUnited StatesUnknown status
Weill Cornell Medicine
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New YorkUnited StatesUnknown status
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
Rhode Island Hospital
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ProvidenceUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
Westchester Medical Center
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ValhallaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.