Combination Immunotherapy for Glioblastoma

Recruiting at39 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Imvax

Prior Safety Data

Trial Summary

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.

Research Team

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.

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.

Treatment Details

Interventions

• IGV-001 (Cell Immunotherapy)
• Placebo (Other)
• Standard of Care (SOC): Radiation Therapy (Radiation)
• Temozolomide (Chemotherapy)

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

Group I: IGV-001 Experimental Treatment 3 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: Placebo Placebo Group 3 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).

Who Is Running the Clinical Trial?

Imvax

Lead Sponsor

Trials

1

Recruited

90+