GBM AGILE Trial (Adaptive Global Innovative Learning Environment)

GBM AGILE (Adaptive Global Innovative Learning Environment) is a seamless clinical trial aimed at identifying the most effective therapies for patients with glioblastoma, the most aggressive form of brain cancer. Led by the trial sponsor Global Coalition for Adaptive Research (GCAR), we were the first in the world to enroll a patient in the GBM AGILE Trial.

This next-generation clinical trial program and adaptive platform trial for brain cancer moves away from the traditional, one-size-fits-all approach to clinical trials; it is a major step forward for precision medicine.

Current glioblastoma treatments have been refined — including surgery, radiation and chemotherapy — but in the era of molecular medicine, immunotherapy and targeted therapies, dramatic leaps in outcomes may be more attainable with this clinical trial.

What is the GBM AGILE difference

Traditional clinical trials:

• Take three to seven years to produce results
• Cannot be modified once started
• Study only one treatment against the standard of care

GBM AGILE changes the model by evaluating multiple therapies simultaneously to more efficiently and rapidly identify effective therapies for patients with glioblastoma. 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 glioblastoma.

The efficiency, speed and learning of GBM AGILE allows for rapid discovery of better treatments for patients with glioblastoma.