PEGARGIMINASE for Glioblastoma

Inclusion criteria

• {"criterion_text":"- All patients: Age ≥ 18 years"}
• {"criterion_text":"- Recurrent: Baseline MRI performed within 14 days prior to randomization"}
• {"criterion_text":"- Recurrent: Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization"}
• {"criterion_text":"- Recurrent: Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed."}
• {"criterion_text":"- Newly Diagnosed: 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. A diagnosis made based on molecular characteristics alone is not allowed"}
• {"criterion_text":"- Newly Diagnosed: An MRI scan performed within 21 days prior to randomization preferably"}
• {"criterion_text":"- Newly Diagnosed: Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization"}
• {"criterion_text":"- Newly Diagnosed: Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization"}
• {"criterion_text":"- Newly Diagnosed: Availability of tumor tissue representative of GBM from definitive surgery or biopsy."}
• {"criterion_text":"- Recurrent: Histologically confirmed GBM, inclusive of gliosarcoma (WHO criteria 2016; IDH wild-type) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum Radiation Therapy (RT). (prior therapy with proton radiation or short course radiation is acceptable)"}
• {"criterion_text":"- Recurrent: Evidence of recurrent disease (RD) demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria"}
• {"criterion_text":"- Recurrent: Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization"}

Exclusion criteria

• {"criterion_text":"- Newly Diagnosed: Any prior treatment for glioma including: prior prolifeprospan 20 with carmustine wafer; prior intracerebral agent; intratumoral, or cerebral spinal fluid (CSF) agent; prior radiation treatment (including proton radiation and short course radiation) for GBM or lower-grade glioma; prior chemotherapy or immunotherapy for GBM or lower-grade glioma"}
• {"criterion_text":"- Newly Diagnosed: QTc > 470 msec"}
• {"criterion_text":"- Newly Diagnosed: History of another malignancy in the previous 2 years, with a diseasefree interval of < 2 years. Note: Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible"}
• {"criterion_text":"- Recurrent: Early disease progression prior to 3 months (12 weeks) from the completion of RT"}
• {"criterion_text":"- Recurrent: 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)"}
• {"criterion_text":"- Recurrent: Any prior treatment with lomustine, experimental agents currently enrolling in the GBM AGILE trial, and bevacizumab or other VEGF)- or VEGF receptor-mediated targeted agent"}
• {"criterion_text":"- Recurrent: Any prior treatment with prolifeprospan 20 with carmustine wafer"}
• {"criterion_text":"- Recurrent: Any prior treatment with an intracerebral agent"}
• {"criterion_text":"- Recurrent: Receiving additional, concurrent, active therapy (including experimental) for GBM outside of the trial"}
• {"criterion_text":"- Recurrent: Extensive leptomeningeal disease"}
• {"criterion_text":"- Recurrent: QTc > 470 msec"}
• {"criterion_text":"- Recurrent: History of another malignancy in the previous 2 years, with a diseasefree interval of < 2 years. Note: Participants with prior history of in situ cancer or basal or squamous cell skin cancer are eligible"}
• {"criterion_text":"- Newly Diagnosed: Receiving additional, concurrent, active therapy (including experimental) for GBM outside of the trial"}
• {"criterion_text":"- Newly Diagnosed: Extensive leptomeningeal disease Leptomeningeal disease in the region of the primary tumor and confined to the supratentorial area is allowed"}

Primary endpoints

• {"endpoint_text":"- Overall Survival defined from the time of randomization to death from any cause","definition_or_measurement_approach":"Overall Survival defined from the time of randomization to death from any cause"}

Secondary endpoints

• {"endpoint_text":"- Progression-Free Survival defined as the time from randomization to clinically determined progression or death from any cause","definition_or_measurement_approach":"Progression-Free Survival defined as the time from randomization to clinically determined progression or death from any cause"}
• {"endpoint_text":"- Tumor Response: complete response, partial response, progressive disease, stable disease","definition_or_measurement_approach":"Tumor response categories recorded as complete response, partial response, progressive disease, or stable disease (as determined clinically / per trial RANO adaptations)"}
• {"endpoint_text":"- Duration of Response: - Complete Response and Partial Response defined as time from date of response to date of clinically determined disease progression or death from any cause","definition_or_measurement_approach":"Duration of Response defined as time from date of response (complete or partial) to date of clinically determined disease progression or death from any cause"}

France

Earliest CTIS Part Ii Submission Date

04-03-2024

Latest Decision Or Authorization Date

11-02-2026

Processing Time Days

709

Number Of Sites

4

Number Of Participants

60

Germany

Earliest CTIS Part Ii Submission Date

04-03-2024

Latest Decision Or Authorization Date

09-02-2026

Processing Time Days

707

Number Of Sites

7

Number Of Participants

60

Primary sponsor

Full Name

Global Coalition For Adaptive Research Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Medidata Solutions Inc.

Responsibilities

Medical image analysis/ review - X-ray, MRI, ultrasound

Name

Voiant Clinical

Responsibilities

Medical image analysis/ review - X-ray, MRI, ultrasound, etc.

Name

Syneos Health Clinique Inc.

Responsibilities

PK analyses for the Troriluzole arm

Name

Iqvia Biotech LLC

Responsibilities

Operational/other study functions (multiple sponsor duties listed; specific responsibilities not fully detailed in provided data)

Name

Almac Clinical Technologies LLC

Responsibilities

Secondary Packaging and Labelling

Name

Labcorp Central Laboratory Services LP

Responsibilities

Tissue Samples, biospecimen shipment/storage and PK sample shipments. MGMT promoter methylation test

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Voiant Clinical","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Industry"}
• {"country":"France","full_name":"Novasco","duties_or_roles":"patient travel reimbursement in France","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"PK analyses for the Troriluzole arm","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Tissue Samples, biospecimen shipment/storage and PK sample shipments. MGMT promoter methylation test","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Berry Consultants LLC","duties_or_roles":"","organisation_type":"Industry"}
• {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"Secondary Packaging and Labelling","organisation_type":"Pharmaceutical company"}