NL-OMON47552已完成3 期
A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination with Radiation Therapy in Newly Diagnosed Adult Subjects with Unmethylated MGMT (tumor O-6-methylguanine DNA methyltransferase) Glioblastoma. - CA209-498
Bristol-Myers Squibb0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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 99（—）
入选标准
- •Subjects must:
- •- Provide signed written informed consent before the performance of any
- •protocol related procedures that are not part of normal subject care.
- •- Be willing and able to comply with scheduled visits, treatment schedule, lab
- •tests, and other requirements of the study including disease assessment by MRI.
- •TARGET POPULATION
- •- Males and Females age >=*18 years old;
- •- Newly diagnosed histologically confirmed supratentorial glioblastoma (Grade 4
- •malignant glioma by World Health Organization including gliosarcoma)
- •- No treatment for GBM other than surgery;
- •- Post-operative baseline MRI must be obtained prior to randomization. It is
- •strongly recommended that this scan be obtained <72 hrs or >14 days
- •post-surgery in order to minimize artifact;
- •- Substantial recovery from surgical resection
- •- No major ongoing safety issues following surgery
- •- <=20 mg prednisone daily or <=*3 mg dexamethasone daily (or equivalent)
- •- Centrally confirmed unmethylated MGMT GBM
- •- Karnofsky performance status of >= 70
- •- Eligible for radiation therapy based on NCCN guidelines
排除标准
- •Subjects must not:
- •-Have had prior treatment for GBM (other than surgical resection)
- •-Have had recurrent GBM
- •-Have had biopsy only of GBM at surgery, defined as <20% resection
- •-Require ongoing treatment with supraphysiologic steroid defined as >20 mg
- •prednisone daily or >3 mg dexamethasone
- •daily (or equivalent), due to intracranial mass effect
- •-Have CNS hemorrhage of Grade >1 on baseline MRI scan, unless subsequently
- •documented to have resolved
- •-Have any known metastatic extracranial or leptomeningeal disease
- •-Have had diagnosis of secondary glioblastoma (i.e., progression from prior
- •low-grade or anaplastic astrocytoma)
- •-Subjects with prior hypersensitivity to dacarbazine (DTIC), ADDITIONAL FOR PET
- •TRACER SUB STUDY:
- •Additional exclusion criteria for PET imaging. Subjects with the following
- •condition(s) will not undergo the PD-L1 PET imaging:
- •- Participants with issues that prevent them from lying still for PET imaging
- •- Participants who have received therapeutic radiopharmaceutical within 7 days
- •participation in this study.
- •- Participants who do not have adequate venous access for PET tracer injection.
- •- Participants with clinical FDG-PET scans performed within 24 hours prior to
- •injection of either study radiotracer ([18F]BMS-986192 or [89Zr]BMS-986289).
- •- Participants with history of prior radiation exposure for research purposes
- •(eg, x-ray,
- •computed tomography scans, or PET research study(ies)) within the past year
- •participation in this study would place them over the limit for annual
- •radiation exposure. This
- •guideline is an effective dose equivalent to 15 rem received per year.
研究者
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