GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), an international collaborative effort, is the world’s first global adaptive clinical trial platform for glioblastoma (GBM).GBM AGILE is challenging the existing standard of clinical trial model that is ineffective for GBM, to yield more effective results for patients.  

Unfortunately, the standard clinical trial model threatens the ability to deliver new and improved treatments to patients facing a diagnosis of glioblastoma. More than 90% of GBM patients will have died in the time it takes to test a single drug.  Efforts to bring any one particular new product to market may last more than eight years, cost hundreds of millions of dollars per treatment tested, require an enormous amount of devotion and leave us no closer to a cure than when the process all started.

The solution is GBM AGILE which changes the model by evaluating multiple therapies simultaneously to more efficiently and rapidly identify effective therapies for GBM patients. Drugs that show initial evidence of benefit to patients will seamlessly transition to a confirmatory stage designed to support drug approval. Drugs that are underperforming are dropped. The intent is to lower the cost, time, and number of patients required to evaluate potential new, effective therapies for patients with GBM. 

GBM AGILE is sponsored by the Global Coalition for Adaptive Research (GCAR) a nonprofit organization comprised of some of the world’s foremost clinical, translational, and basic science investigators, including the National Foundation for Cancer Research. 

This coalition has developed a more “AGILE” approach to defeating GBM, with the goal of enabling faster and more efficient testing of new agents and combination therapies, better identification of predictive and prognostic biomarkers and delivery of more effective treatments to all glioblastoma patients. 

GBM AGILE adaptive clinical trial is open and enrolling patients. (clinicaltrial.gov identifier: NCT03970447)  Learn more about this trial here.