For Health Care Providers

Each year, more than 13,000 people living in the U.S. and tens of thousands more worldwide will receive a diagnosis of glioblastoma. GBM AGILE has the potential to substantially reduce development time for new therapies and biomarker discovery.

 

What is GBM AGILE?

GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) is a flexible and adaptable trial approach that evaluates several treatment arms simultaneously and/or over time, giving it the potential to fundamentally change the clinical research process for glioblastoma (GBM) by identifying or disproving therapies more quickly. This will help to usher in a new generation of effective treatments for GBM, the most common and the deadliest type of brain cancer.

This new clinical trial approach is advantageous to GBM patients because it will help to identify effective treatments faster, allowing researchers to simultaneously and dynamically study the effects of multiple unique drugs.

GBM AGILE uses adaptive randomization to dynamically adjust how treatments are assigned to patients. If one treatment arm outperforms another, a higher proportion of new enrollees will be assigned to that treatment arm. Simply put, GBM AGILE is patient-centric and provides a streamlined method for researchers to utilize data connectivity within the trial to answer many questions concurrently.

 

Why GBM AGILE?

While there have been innovative and cutting-edge advancements in biomedical research, GBM treatment options and patient outcomes have remained largely unchanged over several decades. Despite previous efforts to improve patient prognosis, GBM kills 95% of patients within five years of diagnosis, with more than half of patients succumbing to the disease within the first 15 months after diagnosis.

Determined to make a difference and improve patient outcomes, an international group of more than 130 clinicians, researchers, biostatisticians, imaging specialists, pathologists, patient advocates, and leaders from government and industry known as the “GBM Knowledge Network,” united to develop an entirely new approach to fighting GBM – they conceived of GBM AGILE.

GBM AGILE is a bold vision to change our clinical trial paradigm and revolutionize the way new therapies and biomarkers are developed for patients with glioblastoma. We aim to transform clinical care into an optimized learning environment where patients have access to the latest, most personalized therapies on a global scale.

 

What is the goal of GBM AGILE?

GBM AGILE is a seamless Phase II (Efficacy and Safety) / Phase III (Confirmatory) adaptive platform trial to identify effective therapies and the most promising biomarker-defined populations for those therapies in patients with glioblastoma. GBM AGILE is uniquely designed as a long-standing platform trial with the ability to test multiple therapies concurrently against a common control (standard of care). This enables more patients on trial to get access to experimental therapies. The intent is to lower the cost, time and number of patients required to evaluate potentially effective therapies for GBM patients.

 

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.

 
GBM AGILE