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

  • STATUS
    Recruiting
  • End date
    Jun 15, 2024
  • participants needed
    1030
  • sponsor
    Global Coalition for Adaptive Research
Updated on 15 July 2021
karnofsky performance status
MRI
recurrent disease
temozolomide
gliosarcoma
recurrent glioblastoma
lomustine

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.

Description

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.

Details
Condition Glioblastoma Multiforme, glioblastoma
Treatment Regorafenib, Temozolomide, Radiation, Lomustine, Paxalisib, VAL-083, VAL-083
Clinical Study IdentifierNCT03970447
SponsorGlobal Coalition for Adaptive Research
Last Modified on15 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Recurrent Inclusion Criteria
Age 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
Karnofsky performance status 70% performed within a 14-day window prior to randomization
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
Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed

Exclusion Criteria

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 > 450 msec if male and QTc > 470 msec if female
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
Recurrent Exclusion Criteria
Early disease progression prior to 3 months (12 weeks) from the completion of RT
More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy.)
Received any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent
Any prior treatment with prolifeprospan 20 with carmustine wafer
Any prior treatment with an intracerebral agent
Receiving additional, concurrent, active therapy for GBM outside of the trial
Extensive leptomeningeal disease
QTc > 450 msec if male and QTc > 470 msec if female
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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