With little advancements in the treatment for GBM in more than a decade, the American Brain Tumor Association (ABTA) has joined an international coalition comprised of over 130 neurosurgeons, neuro-oncologists, pathologists, imagers, basic and clinical investigators, and brain tumor advocacy organizations to identify successful therapies for GBM with the launch of the GBM AGILE clinical trial.
GBM AGILE is a global clinical trial that aims to include a large number of ethnically diverse patients with the goal of changing patient outcomes for the better. The “adaptive” trial design concept provides an innovative approach to ensure that we learn from every patient entering the trial. Using a statistically driven design and incorporating biomarkers to divide GBM into subclasses, GBM AGILE will more rapidly and efficiently test single agents and combinations of drugs and biologics. Beyond increasing the numbers of agents tested and the speed of the screening process, effective therapies can process quickly and more cost-effectively to graduate from GBM AGILE to a confirmatory phase III trial.
The adaptive trial design will also address one of the major barriers in identifying effective drugs for GBM which is the lack of validated biomarkers. Since GBM AGILE is a standing trial that will learn from every patient as the trial proceeds, it will be possible to qualify and even validate selected biomarkers.
GBM AGILE is being developed through the National Biomarker Development Alliance (NBDA), a non-profit organization created as part of the Research Collaboratory at Arizona State University (ASU). The trial aims to begin patient enrollment by mid-year.
To learn more about GBM AGILE, go to http://nbdabiomarkers.org/gbm-agile