GBM AGILE | Overview

GBM AGILE — an Adaptive Global Innovative Learning Environment

GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) evaluates investigational therapies for patients with newly diagnosed and recurrent  GBM – the deadliest brain cancer – and determines if any study treatment(s) improve overall survival as compared to standard treatments. An expert in developing and operationalizing adaptive platform trials and master protocols, Global Coalition for Adaptive Research (GCAR), a non-profit corporation, is a global delivery organization for GBM AGILE.

Designed by GCAR as a learning system to more efficiently and rapidly identify effective therapies, GBM AGILE’s nimble model enables multiple drugs (and combinations of drugs) to be screened simultaneously and over time. The intent is to lower the cost, time, and number of patients required to evaluate new potentially effective therapies for GBM patients faster and more efficiently than ever before.

COLLABORATIVE

  • GBM AGILE generates new evidence on available and novel treatments through partnerships with industry and in collaboration with clinical and science investigators, patient advocates and multiple healthcare systems.

REVOLUTIONARY

  • A bold vision to change the clinical trial paradigm and revolutionize the way new therapies and biomarkers are developed for GBM patients. 

PATIENT-CENTRIC

  • GBM AGILE is patient-centric and uses adaptive randomization to dynamically adjust how treatments are assigned to patients. 

SEAMLESS

  • GBM AGILE is a seamless Phase II/Phase III adaptive randomization platform trial designed to rapidly identify effective therapies and the most promising biomarker-defined populations for those therapies in GBM patients and to support new drug approvals and registration.

ACCESSIBLE

  • The trial is currently open for enrollment across multiple clinical trial sites (e.g. university  research centers, hospitals, and cancer institutes) throughout North America, Europe, and Australia. GCAR is working actively to open additional clinical trial sites internationally to enable greater access.

THE CHALLENGE

There is currently no known cure for glioblastoma.

The standard clinical trial model threatens the ability to deliver new and improved treatments to patients facing a diagnosis of glioblastoma. 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, and leave us no closer to a cure than when the process started.

15

Median Survival for Patients with GBM is just under 15 months

48 %

GBM accounts for 48% of all primary malignant brain cancers

3

Only 3 drugs for GBM have been approved over the last 40 years

THE GBM AGILE STRATEGY

GBM AGILE promises to revolutionize the way new therapies and biomarkers are developed for GBM patients. It will dramatically decrease clinical development costs for drug makers and favor increased clinical trial involvement of patients due to its innovative and efficient design. The intent is to effectively lower the bar for entry by pharmaceutical companies into GBM.

Benefits of GBM AGILE

  • Serves as a long-standing platform to test multiple therapies concurrently and over time against a common control (or standard of care) thus enabling more patients on trial to get access to experimental therapies
  • Ability to accelerate the evaluation of new experimental therapies, learning quickly which therapies are effective and which are not
  • Potential to substantially reduce discovery time for new biomarkers
  • Uses overall survival as an endpoint so the data can be used for drug registration in multiple countries.
  • Open to all indications (both newly diagnosed and recurrent patients), establishing a “learning environment” with the goal that every person with GBM could enroll, and the trial and clinic would become indistinguishable.
  • Provides a new clinical research model and prototype for combating other rare and deadly diseases.

Clinical practice and clinical research will better align to increase access to experimental therapies for patients while maximizing what is learned to speed the development of new therapies and biomarkers. This will help to usher in a new generation of effective treatments for glioblastoma, the most common and the deadliest type of brain cancer accounting for 45% of all malignant brain tumors (CBTRUS Statistical Report).

Join GBM AGILE in the Fight Against Brain Cancer.

240 k

240,000 people worldwide are diagnosed with GBM each year

95 %

GBM kills 95% of patients within five years of diagnosis

64 yo

Mean age at diagnosis is 64
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