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NCT Number: NCT04485949

A Phase 2b Clinical Study With a Combination Immunotherapy 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

IGV-001 Cell Immunotherapy

Combination Product

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

Placebo

Combination Product

Placebo in implantable biodiffusion chambers containing a predetermined inactive solution.

Standard of Care (SOC): Radiation Therapy

Procedure

Radiation therapy administered per institutional standards.

SOC: Temozolomide

Drug

Temozolomide administered orally.

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: Up to 36 months

    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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 48 months

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

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

    Time frame: Up to 36 months

    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.

  3. Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

    Time frame: Up to 36 months

  4. Number of Participants With Clinically Significant Vital Signs Measurements

    Time frame: Up to 36 months

  5. Number of Participants With Clinically Significant Physical Examination Findings

    Time frame: Up to 36 months

Other outcomes

  1. Time to Deterioration of Karnofsky Performance Status (KPS) Score

    Time frame: Up to 36 months

    Time to KPS deterioration is defined as the time from screening to the first date of deterioration of the KPS score. Deterioration of KPS is defined as a stable or increasing steroid dose-dependent stabilization of a KPS score of <70 over 2 consecutive visits at least 4 weeks apart. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks.

  2. PFS in Participants With O6-methylguanine-DNA Methyltransferase (MGMT) With Methylation [MGMT+] and MGMT Without Methylation [MGMT-]

    Time frame: Up to 36 months

    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. MGMT status will be determined per epigenetic and tumor proliferation analysis from tissue obtained during surgery.

  3. OS in Participants With MGMT+ and MGMT-

    Time frame: Up to 48 months

    OS is defined as the time from randomization to death due to any cause. MGMT status will be determined per epigenetic and tumor proliferation analysis from tissue obtained during surgery.

Sponsors and collaborators

Lead sponsor

Imvax

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2020
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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