Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM)
- Conditions
- Oncology - Glioblastoma (GBM)MedDRA version: 20.0Level: PTClassification code: 10018336Term: Glioblastoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-511452-40-00
- Lead Sponsor
- Global Coalition For Adaptive Research Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1645
All patients: Age = 18 years, Recurrent: Baseline MRI performed within 14 days prior to randomization, Recurrent: Karnofsky performance status = 70% performed within a 14-day window prior to randomization, Recurrent: Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed., 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, Newly Diagnosed: An MRI scan performed within 21 days prior to randomization preferably, Newly Diagnosed: Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization, Newly Diagnosed: Karnofsky performance status = 60% performed within a 14-day window prior to randomization, Newly Diagnosed: Availability of tumor tissue representative of GBM from definitive surgery or biopsy., 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), Recurrent: Evidence of recurrent disease (RD) demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria, Recurrent: Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization
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, Newly Diagnosed: QTc > 450 msec if male and QTc > 470 msec if female, 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, Recurrent: Early disease progression prior to 3 months (12 weeks) from the completion of RT, 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), 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, Recurrent: Any prior treatment with prolifeprospan 20 with carmustine wafer, Recurrent: Any prior treatment with an intracerebral agent, Recurrent: Receiving additional, concurrent, active therapy (including experimental) for GBM outside of the trial, Recurrent: Extensive leptomeningeal disease, Recurrent: QTc > 450 msec if male and QTc > 470 msec if female, 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, Newly Diagnosed: Receiving additional, concurrent, active therapy (including experimental) for GBM outside of the trial, Newly Diagnosed: Extensive leptomeningeal disease Leptomeningeal disease in the region of the primary tumor and confined to the supratentorial area is allowed
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To identify experimental therapies that improve overall survival (OS) for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment<br>2. To confirm identified efficacious experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application;Secondary Objective: To evaluate Progression Free Survival (PFS), duration of response, and tumour response by each biomarker/therapeutic combination, To evaluate OS by each biomarker/therapeutic combination, To determine short- and long-term safety signals and quality of life (QOL) measures of an experimental Arm in GBM patients versus standard of care;Primary end point(s): Overall Survival defined from the time of randomization to death from any cause
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Progression-Free Survival defined as the time from randomization to clinically determined progression or death from any cause;Secondary end point(s):Tumor Response: complete response, partial response, progressive disease, stable disease;Secondary end point(s):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