EUCTR2015-003739-37-IT进行中(未招募)1 期
A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combinationwith Radiation Therapy in Newly Diagnosed Adult Subjects with Unmethylated MGMT (tumorO-6-methylguanine DNA methyltransferase) Glioblastoma - CheckMate498
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males and Females, age >/ = 18 years old
- •Newly-diagnosed brain cancer or tumor called glioblastoma or GBM
- •Tumor test result shows MGMT unmethylated type
- •Karnofsky performance status of >/= 70 (able to care for self)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 960
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •Prior treatment for GBM (other than surgical resection)
- •Any known tumor outside of the brain
- •Recurrent or secondary GBM
- •Active known or suspected autoimmune disease
- •Biopsy with less than 20% of tumor removed
研究者
相似试验
进行中(未招募)
1 期
Study of Nivolumab versus Temozolomide, given with radiation therapy, for newly-diagnosed patients with glioblastoma (GBM, a malignant brain cancer)EUCTR2015-003739-37-PLBristol-Myers Squibb International Corporation1,200
进行中(未招募)
1 期
Study of Nivolumab versus Temozolomide, given with radiation therapy, for newly-diagnosed patients with glioblastoma (GBM, a malignant brain cancer)EUCTR2015-003739-37-NLBristol-Myers Squibb International Corporation640
进行中(未招募)
1 期
A Randomized Study of Nivolumab versus Bevacizumab and a Safety Study of Nivolumab or Nivolumab combined with Ipilimumab in Adult Subjects with Recurrent Glioblastoma (GBM)Recurrent glioblastomaMedDRA version: 18.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003738-34-NLBristol-Myers Squibb International Corporation550
进行中(未招募)
1 期
Study of Nivolumab versus Temozolomide, given with radiation therapy, for newly-diagnosed patients with glioblastoma (GBM, a malignant brain cancer)EUCTR2015-003739-37-SEBristol-Myers Squibb International Corporation1,200
进行中(未招募)
不适用
Study of Nivolumab versus Temozolomide, given with radiation therapy, for newly-diagnosed patients with glioblastoma (GBM, a malignant brain cancer)nmethylated MGMT (tumor O-6-methylguanine DNA methyltransferase) GlioblastomaMedDRA version: 18.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-003739-37-ESBristol-Myers Squibb International Corporation640
