Phase 2b Study of Combination Immunotherapy for Newly Diagnosed Glioblastoma Patients
Sponsor: Imvax
Sponsor score: 0
ClinicalTrials ID:NCT04485949
This clinical trial is testing a new combination immunotherapy treatment to see if it can help patients with newly diagnosed glioblastoma live longer without their cancer getting worse, compared to a placebo.
Patient Parameters
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Program Overview
The study aims to find out if a new combination immunotherapy treatment, called IGV-001, can help patients with newly diagnosed glioblastoma (a type of brain cancer) live longer and prevent the cancer from worsening, compared to a placebo treatment.
Eligibility Criteria
Inclusion Criteria
- Have a good level of daily functioning, with a Karnofsky performance score of 70 or higher.
- Recently diagnosed with glioblastoma, a type of brain cancer, based on a doctor's assessment.
- Have a brain MRI scan showing a measurable tumor before surgery, with at least one tumor measuring 4 cm² in two different directions.
- The tumor must be located in the upper part of the brain.
- Have good bone marrow and organ function based on screening tests.
Exclusion Criteria
- Have cancer affecting both sides of the brain, multiple tumor sites, or tumors in the brain stem or cerebellum.
- Have had any previous surgery or treatment for glioma.
- Have a history of glioma or another cancer within the last 3 years, unless it was treated and cured, except for certain skin cancers or early-stage cervical or breast cancer.
- Have a severe immune system condition, like HIV with low CD4+ cell count, or an active autoimmune disease like Crohn's disease.
- Have active heart disease or a history of heart problems.
- Are taking part in another treatment study or have taken an experimental drug recently.
- Have received a live vaccine within 30 days before the study.
- Have active and untreated infections like hepatitis B, hepatitis C, or HIV.
- Are using Tumor Treating Fields or Optune® therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic - Jacksonville | 32224 | Jacksonville | Florida |
| Tufts Medical Center | 02111 | Boston | Massachusetts |
| Henry Ford Health System | 48202 | Detroit | Michigan |
| Dartmouth Hitchcock Medical Center | 03756 | Lebanon | New Hampshire |
| John Theurer Cancer Center At Hackensack UMC | 07601 | Hackensack | New Jersey |
| Jersey Shore University Medical Center | 07753 | Neptune City | New Jersey |
| Northwell Health at North Shore University Hospital | 11030 | Manhasset | New York |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | 10021 | New York | New York |
| Icahn School of Medicine at Mount Sinai | 10029 | New York | New York |
| Columbia University Medical Center | 10032 | New York | New York |
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