EUCTR2013-003738-34-DK进行中（未招募）1 期
A Randomized Phase 3 Open Label Study of Nivolumab versus Bevacizumab and a Safety Study of Nivolumab or Nivolumab in Combination with Ipilimumab in Adult Subjects with Recurrent Glioblastoma (GBM) - CheckMate143
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
- 550
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
- •Subjects with histologically confirmed Grade IV malignant glioma
- •Previous treatment with radiotherapy and temozolomide
- •Documented first recurrence of GBM
- •Karnofsky PS = 70
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 440
排除标准
- •More than one recurrence of GBM.
- •Presence of extracranial metastatic or leptomeningeal disease.
- •Active, known or suspected autoimmune disease
- •Prior bevacizumab or other VEGF or anti-angiogenic treatment (cohort 2 only)
- •Clinically significant cardiovascular disease
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