What does a Phase 2 trial investigate?
Generally, Phase 2 trials 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 the effectiveness of a new drug or drugs.
What is the design of the Phase 2 study?
Based on the encouraging results in the Phase 1 trials, Imvax has initiated a Phase 2b trial 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 you, your doctors, and your treatment team will not know if you are receiving IGV-001 or the placebo. In rare cases, your treatment can be revealed (unblinded) if your 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) following 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 the Phase 2 study is that you must have glioblastoma that is newly diagnosed, without starting chemotherapy or radiation yet. Other important requirements for your eligibility in the study, such as your general health and other medications will be reviewed and discussed with you by your doctor and research team. Not all patients with ndGBM will be eligible for this study.
What happens if I’m interested in enrolling?
Once the study, including risks, benefits, and other treatment options, have been discussed with you and if you are willing to proceed in the study, you will be asked to sign an informed consent form, acknowledging that you are willing to proceed with the study treatment. You can withdraw your consent to participate in the study at any time and for any reason you decide. Procedures that you may be financially responsible for will also be discussed, although in most cases these procedures can be billed to your insurance company.
How is my eligibility determined?
Once you sign the consent form, your research team will begin scheduling and performing various tests required to determine your eligibility for the study. These will include items such as scans, blood tests, and tests on your heart, for example. When all of these tests are performed, and the results are satisfactory, you will be scheduled for surgery on your brain tumor. Your treatment team will provide a schedule for all of these. If you are determined to not be eligible for the study, your treatment team will discuss other treatment options with you.
Where is the study taking place?
You can find the study listing (NCT04485949) in www.clinicaltrials.gov.These are currently the sites participating in the study:
Additional study sites will be added soon. Please check back regularly for additional information or
get in touch with our clinical affairs team with any other key questions.