GBM AGILE is a clinical trial for newly diagnosed and recurrent glioblastoma patients, age 18 or older. For more information on taking part in a clinical trial, please visit our website for more information.

The GBM AGILE clinical trial is currently open at multiple clinical sites (e.g., university research centers, hospitals, and cancer institutes) across the globe. To participate in GBM AGILE, you need to enroll through one of GBM AGILE’s trial sites. Please refer to GBM AGILE Trial Sites for a continuously updated list of trial locations. 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.

The GBM AGILE clinical trial is currently open at multiple clinical sites (e.g., university research centers, hospitals, and cancer institutes) across the globe. Please refer to GBM AGILE Trial Sites for a continuously updated list of trial locations.

Unfortunately, you must receive treatment at one of GBM AGILE Trial Sites to participate. We are working actively to open additional clinical trial sites to enable greater access to GBM AGILE for interested and eligible patients.

Please refer to GBM AGILE Trial Sites for a continuously updated list of trial locations. Follow us on Twitter or Facebook for important updates. 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 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 study’s treatment phase. 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 trial’s treatment phase 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.

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

The purpose of this study is to evaluate multiple investigational treatments for patients with either newly diagnosed or recurrent glioblastoma to determine if any of these study treatment(s) improve overall survival as compared to standard treatments. Investigational means that these are new treatments, sometimes called “study drugs” and are not approved by the Food and Drug Administration (FDA) or other regulatory agencies to be used for your type of cancer. The investigational treatments in this study have been previously tested in people. In addition to answering “Is the drug working?,” we are interested in understanding and gaining insight into how you feel when taking the drug. As a participant, various measurements of your quality of life will be captured and analyzed.

For information about the treatments currently being evaluated please visit GBM AGILE on clinicaltrials.gov.

Your study treatment will be randomly assigned, 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 partly determine 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 and other regulatory agencies.

If you are randomized to the control group, you will receive standard care for treating your cancer. Treatment is dependent on the stage of your disease. The medications being used in this control are not considered investigational. They have been approved for use in the treatment of your cancer by the FDA. For newly diagnosed patients, treatment consists of radiation therapy and a chemotherapy drug called temozolomide. For recurrent patients, treatment consists of a chemotherapy drug called lomustine (CCNU).

While we are actively working to create this option, the current trial design does not support the ability to change treatments.

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