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.
All institutions are enrolling Newly Diagnosed participants. Institutions also enrolling Recurrent participants are marked with an asterisk (\*).
Age ≥ 18 years.
Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan with the required imaging sequences performed within 21 days prior to randomization preferably. The post-operative MRI scan performed within 96 hours of surgery or the MRI scan performed for radiation therapy planning may serve as the MRI scan performed during screening if all required imaging sequences were obtained.
Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization.
Availability of tumor tissue representative of GBM from definitive surgery or biopsy.
Received any prior treatment for glioma including: a. Prior prolifeprospan 20 with carmustine wafer. b. Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent. c. Prior radiation treatment for GBM or lower-grade glioma. d. Prior chemotherapy or immunotherapy for GBM or lower-grade glioma. Receiving additional, concurrent, active therapy for GBM outside of the trial.
Extensive leptomeningeal disease.
QTc > 470 msec
History of another malignancy in the previous 2 years, with a disease-free interval of < 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
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Treatment groupsSee each treatment group below.
Global Coalition for Adaptive Research
Lead sponsor
Bayer
Collaborator
Kazia Therapeutics Limited
Collaborator
Kintara Therapeutics, Inc.
Collaborator
Biohaven Pharmaceuticals, Inc.
Collaborator
Vigeo Therapeutics, Inc.
Collaborator
Polaris Group
Collaborator
AstraZeneca
Collaborator
Knoa Pharma
Collaborator