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Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM)
EU CTIS ID: 2024-511452-40-00
What this study is testing
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 2. To confirm identified efficacious experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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 > 470 msec
- 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
See the full eligibility criteria
- 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 > 470 msec
- 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 > 470 msec
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Australia
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Australia; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.