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Cell Immunotherapy

Combination Immunotherapy for Glioblastoma

Phase 2

Waitlist Available

Research Sponsored by Imvax

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 (as assessed by the adapted Response Assessment in Neuro-Oncology [RANO] criteria) 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)

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)

Must not have

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

Has received a live vaccine within 30 days of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Summary

This trial will compare a new treatment for glioblastoma to placebo to see if it extends survival.

Who is the study for?

This trial is for individuals newly diagnosed with Glioblastoma (WHO Grade III or IV). They must have a measurable brain lesion, test positive for certain antigens, have good organ function and performance status (KPS score ≥ 70), and the tumor should be in the supratentorial compartment. Excluded are those with bi-hemispheric disease, prior GBM treatments, other cancers within 3 years (with exceptions), severe immune conditions, heart issues, recent live vaccines or active infections.

What is being tested?

The study tests IGV-001 Cell Immunotherapy against a placebo in patients with Glioblastoma to see if it improves progression-free survival (PFS) and overall survival (OS). All participants will also receive standard care including radiation therapy and Temozolomide chemotherapy.

What are the potential side effects?

Potential side effects of IGV-001 may include typical immunotherapy reactions such as inflammation in various organs, flu-like symptoms, fatigue, possible infusion-related reactions and an increased risk of infection due to immune system modulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a specific brain scan showing a measurable tumor.

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I have had a specific brain scan showing a measurable lesion.

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I have been diagnosed with a high-grade brain tumor (GBM Grade III or IV).

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My tumor is located in the upper part of my brain.

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I am mostly able to care for myself and carry out normal activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My MRI shows cancer has spread to both sides of my brain, brain stem, or cerebellum.

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I have not received a live vaccine in the last 30 days.

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I have had surgery or cancer treatment for brain cancer.

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I have heart problems or a history of heart issues.

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I am currently undergoing treatment with Tumor Treating Fields or Optune®.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS)

Secondary study objectives

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

Overall Survival (OS)

Other study objectives

OS in Participants With MGMT+ and MGMT-

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

Time to Deterioration of Karnofsky Performance Status (KPS) Score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IGV-001Experimental Treatment3 Interventions

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 II: PlaceboPlacebo Group3 Interventions

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).

0 / 10Eligibility criteria met