Our Passion for Patient Care
“Our highest priority and motivation are the patients, families and caregivers.”
Our Clinical Trials in Glioblastoma
GBM is a brain cancer that is nearly always fatal. It is the most common malignant tumor that affects the central nervous system (CNS) and the third most common tumor of the brain and CNS. A person newly diagnosed with GBM currently has a median overall survival (OS) or life expectancy of approximately 12 to 15 months, and less than 6% of GBM patients survive to five years after diagnosis. The existing standard of care is based on a surgery that removes as much of the tumor as possible. This procedure is typically followed by chemotherapy (temozolomide) combined with radiation and then chemotherapy (temozolomide) alone.
IGV-001, Imvax’s most advanced product candidate, is in development to treat GBM. In March 2023, we initiated a randomized, placebo-controlled Phase 2b clinical study of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM) (NCT04485949). More information about this trial can be found further down this page.
Expanded Access Policy
For information about Imvax’s Expanded Access Policy, please click here.
“We are excited about the potential of IGV-001 for the treatment of ndGBM and look forward to fully enrolling this trial and seeing its results.”
What does a Phase 2 trial investigate?
Phase 2 trials generally utilize the same dose and schedule of a drug determined to be safe and effective in Phase 1, but in a larger group of patients. The goals of a Phase 2 trial are to further determine the safety of a new drug and to evaluate its effectiveness. A summary of this study is available in infographic format by clicking on the image.
What is the design of the Phase 2 study?
Based on the encouraging results in the Phase 1 studies, Imvax has initiated a Phase 2b study with IGV-001 in 93 patients with ndGBM. The trial will be run at several cancer centers, generally in the Eastern half of the United States. All patients will have biodiffusion chambers placed in the abdomen after surgery for the brain tumor. One-third (1/3) of the patients will have a placebo (inactive drug) in the biodiffusion chambers, and two-thirds (2/3) will have active IGV-001 in the biodiffusion chambers. The study is blinded, meaning participants, doctors, and treatment teams will not know if they are receiving IGV-001 or the placebo. In rare cases, treatment can be revealed (unblinded) if doctors feel that information is important to know for additional medical care or an emergency. All patients will receive standard chemotherapy (temozolomide) with radiation followed by chemotherapy (temozolomide) alone after recovery from brain tumor surgery, just as was done in the Phase 1 study.
What are the requirements to enroll in the Phase 2 study?
The primary requirement for eligibility in our Phase 2b study is that patients must have newly diagnosed GBM prior to starting chemotherapy or radiation. Other important requirements for patient eligibility in the study, such as general health and other medications, will be reviewed and discussed with doctors and research teams. Most, but not all, patients with ndGBM will be eligible for this study.
What happens if I’m interested in enrolling?
Once the study details, risks, benefits and other treatment options have been discussed with participants, they will be asked to sign an informed consent form, acknowledging that they are willing to proceed with the study. Patients can withdraw their consent to participate in the study at any time and for any reason. Procedures that they may be financially responsible for will also be discussed, although in most cases these procedures can be billed to the patient’s insurance company.
How is my eligibility determined?
Once participants sign the consent form, their research team will begin scheduling and performing various tests required to determine their eligibility for the study. These will include items such as scans, blood tests and tests on their heart. Once all of these tests are performed and the results are satisfactory, patients will be scheduled for surgery on their brain tumor. Treatment teams will provide a schedule for all of these. If a patient is determined to not be eligible for the study, their treatment team will review other treatment options.
Where is the study taking place?
You can find the study listing (NCT04485949) in www.clinicaltrials.gov. The following sites are participating in the study:
- Dartmouth Hitchcock Medical Center, Lebanon, NH
- Tufts Medical Center, Boston, MA
- Rhode Island Hospital, Providence, RI
- Lenox Hill Hospital, New York, NY
- Montefiore Medical Center, New York, NY
- Icahn School of Medicine at Mount Sinai, New York, NY
- Columbia University, New York, NY
- Weill Cornell Medicine, New York, NY
- Westchester Medical Center, Valhalla, NY
- Memorial Sloan Kettering Cancer Center, New York, NY
- Northwell Health at North Shore University Hospital, Manhasset, NY
- Jersey Shore University Medical Center, Neptune, NJ
- Thomas Jefferson University, Philadelphia, PA
- University of Pennsylvania, Philadelphia, PA
- The Pennsylvania State University Milton S. Hershey Medical Center, Hershey, PA
- University of North Carolina, Chapel Hill, NC
- Henry Ford Health System, Detroit, MI
- The Ohio State University, Columbus, OH
- University of Wisconsin, Madison, WI
- Mayo Clinic, Jacksonville, FL
What does a Phase 1 trial investigate?
The primary purpose of a Phase 1 trial is to evaluate the safety of a new drug before it proceeds to further clinical trials. In addition to safety, researchers can answer other questions in a Phase 1 trial such as how much of a drug is measured in the blood after administration, how it works in the body, and/or the side effects associated with increased dosage. A summary of this study is available in infographic format by clicking on the image.
What Phase 1 studies has Imvax conducted?
To date, two Phase 1 clinical studies of IGV-001 in recurrent GBM and ndGBM have been completed that dosed a total of 46 patients. The larger of these trials, a Phase 1b trial of IGV-001 in 33 patients with ndGBM, was conducted and completed at Thomas Jefferson University. The patients in this trial had tumor cells removed by surgery, which were then treated with IMV-001, inserted into biodiffusion chambers and placed into the patient’s abdomen. Patients were randomly assigned to one of four groups, each with a different number of chambers and length of time the chambers stayed in the abdomen. After removing the chambers and recovering from surgery, the patients then went on to receive standard chemotherapy (temozolomide) combined with radiation, followed by chemotherapy (temozolomide). In the Phase 1b trial, the group of patients who received 20 biodiffusion chambers that remained in the abdomen for 48 hours had the most benefit. Both this number of chambers and specific timeframe have been selected for the Phase 2b trial.
What are the conclusions of Imvax’s Phase 1 studies?
The conclusions of this Phase 1b trial were that IGV-001 was safe and well tolerated. Furthermore, progression-free survival (i.e., the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse) compared favorably with data from patients treated in the past with surgery and standard chemotherapy and radiation.
Patients and Community Resources
Clinical trials are highly regulated by federal regulatory agencies. You can find additional information at the website of The U.S. Food and Drug Administration.
Additional information can be found in the following websites:
- American Cancer Society (ACS)
- National Cancer Institute (NCI)
- National Comprehensive Cancer Network (NCCN)
- ClinicalTrials.gov
Imvax is proud to be a sponsor of the following patient advocacy organizations that are providing critical funding and advocacy for brain cancer research and much-needed support for patients and their families. Click on the links below to learn more.
