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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IGV-001

Participants 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).

Group Type EXPERIMENTAL

IGV-001 Cell Immunotherapy

Intervention Type COMBINATION_PRODUCT

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

Standard of Care (SOC): Radiation Therapy

Intervention Type PROCEDURE

Radiation therapy administered per institutional standards.

SOC: Temozolomide

Intervention Type DRUG

Temozolomide administered orally.

Placebo

Participants 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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

Placebo in implantable biodiffusion chambers containing a predetermined inactive solution.

Standard of Care (SOC): Radiation Therapy

Intervention Type PROCEDURE

Radiation therapy administered per institutional standards.

SOC: Temozolomide

Intervention Type DRUG

Temozolomide administered orally.

Interventions

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IGV-001 Cell Immunotherapy

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

Intervention Type COMBINATION_PRODUCT

Placebo

Placebo in implantable biodiffusion chambers containing a predetermined inactive solution.

Intervention Type COMBINATION_PRODUCT

Standard of Care (SOC): Radiation Therapy

Radiation therapy administered per institutional standards.

Intervention Type PROCEDURE

SOC: Temozolomide

Temozolomide administered orally.

Intervention Type DRUG

Eligibility Criteria

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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

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®

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

John Theurer Cancer Center At Hackensack UMC

Hackensack, New Jersey, United States

Site Status

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Site Status