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GBM Agile: Global Adaptive Trial Master Protocol
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.
5.1 Primary Objectives The primary objectives of the study are: 1. To identify experimental therapies that improve OS for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment. 2. To confirm identified efficacious experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application. 5.2 Secondary Objectives The secondary objectives of the study are: 1. To evaluate PFS by each biomarker/therapeutic combination. 2. To evaluate OS by each biomarker/therapeutic combination. 3. To determine short- and long-term safety signals and QOL measures of an experimental Arm in GBM patients versus standard of care. 5.3 Exploratory Objectives The primary objectives of the study are: 1. To generate general prognostic and predictive biomarker hypotheses. 2. To build and validate a longitudinal endpoint model of OS comprised of early assessments (performance status, disease progression, etc.) that are associated with OS.
BAY 73-4506 (Regorafenib); Lomustine (CeeNU); Regorafenib (Stivarga); Temodal (Temozolomide); Temozolomide ()