Combination Immunotherapy for Glioblastoma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are receiving treatment with Tumor Treating Fields or Optune®, you cannot participate in the trial.
What data supports the effectiveness of the drug Temozolomide for glioblastoma?
Research shows that combining Temozolomide with radiotherapy improves survival rates in glioblastoma patients, especially when the MGMT promoter is methylated. Additionally, Temozolomide with intensity modulated radiation therapy enhances immune function and overall treatment effectiveness in glioma patients.12345
Is the combination immunotherapy for glioblastoma safe?
What makes the combination immunotherapy treatment IGV-001 unique for glioblastoma?
The combination immunotherapy treatment IGV-001 is unique because it uses a patient's own glioblastoma tumor cells combined with an antisense oligonucleotide (a small piece of DNA or RNA designed to bind to specific molecules) against the IGF type 1 receptor, aiming to enhance the immune response against the tumor, which is different from standard treatments that typically involve only radiation and chemotherapy.127910
What is the purpose of this trial?
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.
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Implantation
Participants are implanted with biodiffusion chambers containing IGV-001 or placebo on Day 1 and explanted on Day 3
Treatment
Participants receive radiotherapy per institutional standards for 5 days per week along with temozolomide for up to 12 weeks, followed by temozolomide on Days 1 to 5 of each 28-day cycle for up to 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- IGV-001
- Placebo
- Standard of Care (SOC): Radiation Therapy
- Temozolomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Imvax
Lead Sponsor