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A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

Active: Yes
Cancer Type: Brain & Spinal Cord Tumor NCT ID: NCT03970447
Trial Phases: Phase II
Phase III 		Protocol IDs: GCAR-7213 (primary)
NCI-2019-04788
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Global Coalition for Adaptive Research
NCI Full Details: http://clinicaltrials.gov/show/NCT03970447

Summary

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an
international, seamless Phase II/III response adaptive randomization platform trial
designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.

Objectives

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an
international, seamless Phase II/III response adaptive randomization platform trial
designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. Its
goals are to identify effective therapies for glioblastoma and match effective therapies
with patient subtypes. Bayesian response adaptive randomization is used within subtypes
of the disease to assign participants to Arms based on their performance. The primary
endpoint is overall survival (OS).

GBM AGILE is designed to efficiently evaluate therapies. The trial will be conducted
under a single Master Investigational New Drug Application/Clinical Trial Application and
Master Protocol, allowing multiple drugs and drug combinations from different
pharmaceutical companies to be evaluated simultaneously. The plan is to add experimental
therapies as new information about promising new drugs are identified and remove
therapies as they complete their evaluation.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.