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临床试验/EUCTR2015-003739-37-IT
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

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO0 个研究点目标入组 1,200 人开始时间: 2021年6月17日最近更新:
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

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