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Cell Immunotherapy

Combination Immunotherapy for Glioblastoma

Phase 2

Recruiting

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS)

Secondary outcome measures

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

Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

Number of Participants With Clinically Significant Physical Examination Findings

+2 more

Other outcome measures

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImvaxLead Sponsor

Media Library

IGV-001 (Cell Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04485949 — Phase 2

Glioblastoma Research Study Groups: IGV-001, Placebo

Glioblastoma Clinical Trial 2023: IGV-001 Highlights & Side Effects. Trial Name: NCT04485949 — Phase 2

IGV-001 (Cell Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04485949 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age restriction for this research allow individuals under 35 to participate?

"To be eligible for this trial, individuals must have surpassed the age of consent and yet not exceeded 70 years old."

Answered by AI

What is the upper limit on participant enrollment in this experiment?

"This clinical trial is no longer accepting participants; its posting was initially published on December 1st 2022, and the page was last updated June 24th 2022. If you are seeking alternative studies, there are currently 442 trials for glioblastoma patients and 206 related to IGV-001 Cell Immunotherapy that remain open."

Answered by AI

Would I be eligible to join this medical investigation?

"To be eligible for this medical trial, patients must have glioblastoma and fall within the age range of 18 to 70. The team is looking to enroll 93 people in total."

Answered by AI

To what maladies is IGV-001 Cell Immunotherapy typically applied?

"IGV-001 Cell Immunotherapy is often prescribed to patients undergoing nitrosourea treatment, and can be employed in cases of advanced mycosis fungoides, refractory neuroblastoma, advance directives or treatments with limited efficacy."

Answered by AI

What other research efforts have been conducted pertaining to IGV-001 Cell Immunotherapy?

"In 2002, the Memorial Sloan Kettering Cancer Center initiated its research into IGV-001 Cell Immunotherapy. Since then, 18614 clinical trials have been completed with 206 currently active ones concentrated in Philadelphia, Pennsylvania."

Answered by AI

What is the breadth of this experiment's geographical distribution?

"At the moment, 34 medical trial sites are running this clinical study across America with Philadelphia, Newark and Boston being among them. To reduce travel time if you participate in the research, it is important to choose a nearby site location."

Answered by AI

Is recruitment still taking place for this experiment?

"Contrary to the information hosted on clinicaltrials.gov, this medical trial is not enrolling patients as of now; it was first uploaded on December 1st 2022 and its record most recently updated June 24th 20212. However, there are 648 other trials actively recruiting participants at present."

Answered by AI

Is this research novel or has it been conducted elsewhere?

"At present, there are 206 ongoing studies involving IGV-001 Cell Immunotherapy in 935 cities across 36 countries. This experimental drug first underwent clinical trials in 2002 under the auspices of Schering-Plough. Initially testing 60 patients during its Phase 2 approval process, 18614 further trials have been completed since then."

Answered by AI

Has IGV-001 Cell Immunotherapy been given the stamp of approval by the FDA?

"This immunotherapy is still in the process of being evaluated for safety, so it was given a score of 2 on our rating scale. As this is only Phase 2 trial, there are some data points indicating its safety but no information on efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04485949.

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