GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) is a clinical trial to evaluate multiple investigational treatments for either newly diagnosed or recurrent glioblastoma to determine if any of these study treatment(s) improve overall survival as compared to standard treatments.

 

I want to join the GBM AGILE clinical trial. How do I find a center that is participating?

The GBM AGILE clinical trial will take place across multiple clinical sites (e.g., university research centers, hospitals, and cancer institutes) throughout the United States, Canada, Australia, Europe, Asia, and elsewhere.

To participate in GBM AGILE, you need to enroll through one of GBM AGILE‘s trial sites. We will continuously update the GBM AGILE Trial Sites list as new sites open.

PATIENTS DIAGNOSED WITH GLIOBLASTOMA SHOULD NOT DELAY TREATMENT

If you have been diagnosed with glioblastoma and GBM AGILE is not yet available in your area, please consult with your physician to explore other clinical trial options that are available now. If you are located in the United States, please visit trials.braintumor.org or clinicaltrials.gov, for information about currently enrolling clinical research studies.

 

Who can enroll in the GBM AGILE clinical trial?

GBM AGILE is a clinical trial for newly diagnosed and recurrent glioblastoma patients, age 18 or older.

For more information about whether GBM AGILE is right for you, please contact one of the open and enrolling GBM AGILE Trial Sites near you to speak to the clinical trial team. For addition questions, you can also contact a general patient information line at 310-598-3199 or email patientinfo@gcaresearch.org.

 

What will happen if I join the GBM AGILE clinical trial?

If you would like to participate in GBM AGILE, you will be asked to sign a consent form agreeing to be screened for the trial. During the screening phase, you will have tests and procedures performed to determine if you meet the eligibility criteria to participate in the treatment phase of the study. Your study doctor and/or study staff will review your medical chart and ask you questions about your current health and medical history.

If you meet eligibility criteria, you will then be randomized to a treatment group. You may be randomized to an experimental arm or to the control group (which receives the standard of care). You would then consent to the treatment phase of the trial to receive the treatment to which you’ve been randomly assigned.

GBM AGILE is an open-label trial. This means that participants and health care providers are aware of which drug(s) or treatment(s) are being administered.

participate in GBM AGILE

 

How does GBM AGILE decide which treatment arm I would be placed in?

Your study treatment will be assigned randomly, like the flipping of a coin or the rolling of dice. The number of study treatments available at the time of your randomization will be part of the determination of which treatment you will receive. You will not be able to choose which treatment you will receive in the study. Patients are either randomized to an experimental arm (an investigational drug) or to a group receiving the standard of care, also known as the control group. No one will receive a placebo.

Standard of care is treatment that is widely used and accepted by medical experts as a proper treatment for your cancer. The treatment(s) used for the control group are not considered investigational. They have been approved for use in the treatment of your cancer by the FDA.

 

How is GBM AGILE different from other clinical trials?

GBM AGILE is designed as a learning system to more efficiently and rapidly identify effective therapies for GBM. Unlike traditional trials which evaluate one therapy at a time, GBM AGILE may test several therapies or treatment arms simultaneously. New treatment arms can be quickly added and evaluated at any time, while underperforming drugs are dropped from the trial.

 

Who is sponsoring GBM AGILE?

The Global Coalition for Adaptive Research (GCAR), a 501(c)(3) non-profit organization, is the sponsor of the GBM AGILE clinical trial.