A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Brain & Spinal Cord Tumor
18 Years and older, Male and Female
GCAR-7213 (primary)
NCI-2019-04788
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.
Eligibility
- Age â?¥ 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 â?¥ 60% performed within a 14-day window prior to randomization.
- Availability of tumor tissue representative of GBM from definitive surgery or biopsy. Recurrent Inclusion Criteria:
- Age â?¥ 18 years.
- Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum radiation therapy (RT).
- Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.
- Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression.
- Karnofsky performance status â?¥ 70% performed within a 14-day window prior to randomization.
- Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed. Newly Diagnosed
Treatment Sites in Georgia
**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.