93 Participants Needed

Combination Immunotherapy for Glioblastoma

Recruiting at 39 trial locations
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Overseen ByJill Krause
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Temozolomide, a drug used in combination with radiotherapy for glioblastoma, generally has a lower toxicity compared to older chemotherapy drugs, but rare cases of serious blood disorders like therapy-related acute myeloid leukemia have been reported.12678

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

I have had a specific brain scan showing a measurable tumor.
I have had a specific brain scan showing a measurable lesion.
My organs and bone marrow are working well.
See 4 more

Exclusion Criteria

Is partaking in another interventional study. Participants who are partaking in an observational study are eligible
My MRI shows cancer has spread to both sides of my brain, brain stem, or cerebellum.
I have not received a live vaccine in the last 30 days.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Participants are implanted with biodiffusion chambers containing IGV-001 or placebo on Day 1 and explanted on Day 3

3 days
1 visit (in-person)

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

41 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 48 months

Treatment Details

Interventions

  • IGV-001
  • Placebo
  • Standard of Care (SOC): Radiation Therapy
  • Temozolomide
Trial Overview 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.
Participant Groups
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Imvax

Lead Sponsor

Trials
1
Recruited
90+

Findings from Research

In a phase III study involving 716 patients with newly diagnosed glioblastoma, the addition of the immune checkpoint inhibitor nivolumab (NIVO) to standard radiotherapy (RT) and temozolomide (TMZ) did not significantly improve progression-free survival (PFS) or overall survival (OS) compared to placebo, with median OS of 28.9 months for NIVO versus 32.1 months for placebo.
The study found a higher rate of grade 3/4 treatment-related adverse events in the NIVO group (52.4%) compared to the placebo group (33.6%), indicating that while NIVO did not enhance efficacy, it was associated with increased toxicity.
Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter.Lim, M., Weller, M., Idbaih, A., et al.[2023]
In a study of 103 glioblastoma patients treated with standard temozolomide and radiotherapy, the median overall survival was found to be 13.7 months, highlighting the effectiveness of this treatment regimen.
Three key prognostic factors were identified that negatively impacted overall survival: age over 65 years, a Medical Research Council (MRC) scale score of 3-4, and the occurrence of postoperative complications, suggesting that these factors can help predict patient outcomes.
Age, Neurological Status MRC Scale, and Postoperative Morbidity are Prognostic Factors in Patients with Glioblastoma Treated by Chemoradiotherapy.Verlut, C., Mouillet, G., Magnin, E., et al.[2020]
In a study of 79 patients with glioblastoma, the combination of radiotherapy and temozolomide resulted in a median overall survival of 18.3 months and 2-year survival rate of 37.1%, which aligns with previous international studies.
The main side effect observed was hematologic toxicity in 8.8% of patients, indicating that while the treatment is effective, monitoring for blood-related side effects is important.
Clinical outcome of concomitant chemoradiotherapy followed by adjuvant temozolomide therapy for glioblastaomas: single-center experience.Jeon, HJ., Kong, DS., Park, KB., et al.[2018]

References

Radiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: An international randomized phase III trial. [2023]
Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. [2023]
Age, Neurological Status MRC Scale, and Postoperative Morbidity are Prognostic Factors in Patients with Glioblastoma Treated by Chemoradiotherapy. [2020]
Clinical outcome of concomitant chemoradiotherapy followed by adjuvant temozolomide therapy for glioblastaomas: single-center experience. [2018]
Effect of Temozolomide Combined with Intensity Modulated Radiation Therapy on Serum Factor, Immune Function and Clinical Efficacy in Postoperative Glioma Patients. [2023]
Temozolomide in radio-chemotherapy combined treatment for newly-diagnosed glioblastoma multiforme: phase II clinical trial. [2018]
Future directions for temozolomide therapy. [2019]
A Case of Therapy-Related Acute Myeloid Leukemia Associated with Adjuvant Temozolomide Chemotherapy for Anaplastic Astrocytoma. [2018]
Phase I/IIa trial of fractionated radiotherapy, temozolomide, and autologous formalin-fixed tumor vaccine for newly diagnosed glioblastoma. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Phase Ib Clinical Trial of IGV-001 for Patients with Newly Diagnosed Glioblastoma. [2022]
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