CTIS2024-511452-40-00招募中1 期
GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM) - GCAR-7213
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,645
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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