Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM

Sponsor:

Global Coalition for Adaptive Research (GCAR)

Sponsor Study ID:

12845

CTO #:

103147

NCT Number:

NCT03970447

Phase:

II/III

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Brain and Nervous System

Study Objectives:

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.

eConsent:

Not available

Study Documents:

Open Study Documents
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