ENROLLMENT AND TRIAL LOCATIONS

 

How do I enroll in GBM AGILE?

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

If you would like to participate in GBM AGILE you will be asked to sign a screening 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 criteria to participate in the treatment phase of the study.

 

Where can I participate?

The GBM AGILE clinical trial will take place across multiple clinical sites (e.g., university research centers, hospitals, and cancer institutes) across the globe.

GBM AGILE clinical trial sites in the United States will open on a rolling basis beginning in May 2019.

Please refer to GBM AGILE Trial Sites for a continuously updated list of trial locations.

 

Can I participate remotely?

Unfortunately, no. You need to receive treatment at one of GBM AGILE Trial Sites to participate. We are working actively to open clinical trial sites around the U.S. and internationally to enable greater access to GBM AGILE for interested and eligible patients.

 

When will the trial open in other countries?

We will keep this information as up to date as possible as information changes. Currently, we are working to open in Canada, Europe, and China in 2020.

Please follow us on Twitter or Facebook and join our email list 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 are located in the United States, please visit trials.braintumor.org or clinicaltrials.gov, for information about currently enrolling clinical research studies.

 

ELIGIBILITY CRITERIA

 

Who is eligible for GBM AGILE?

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.

 

GENERAL

 

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 tested at any time. Drugs showing initial evidence of benefit seamlessly transition to a confirmatory stage while underperforming drugs are dropped from the trial.

 

What the purpose of GBM AGILE?

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) 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.

 

What treatments will be included in GBM AGILE?

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

 

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.

 

If I am randomized to the control group, what treatment will I receive?

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). Additional information can be found at clinicaltrials.gov

 

If I enroll in GBM AGILE and the treatment I receive shows no benefit, will I be able to switch to a different treatment in the trial?

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

 

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.