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 (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 560
- 试验地点
- 115
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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)
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
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Nivolumab + Radiotherapy Arm
Nivolumab IV infusion + Radiotherapy dose as specified
干预措施: Nivolumab (Drug)
Nivolumab + Radiotherapy Arm
Nivolumab IV infusion + Radiotherapy dose as specified
干预措施: Radiotherapy (Radiation)
Temozolomide + Radiotherapy Arm
Temozolomide + Radiotherapy dose as specified
干预措施: Temozolomide (Drug)
Temozolomide + Radiotherapy Arm
Temozolomide + Radiotherapy dose as specified
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Overall Survival (OS)
时间窗: up to 3 years
OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.
次要结局
- Kaplan-Meier Plot of Progression Free Survival(From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years))
- Progression Free Survival in Tumor Mutational Burden (TMB) High Population(From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years))
- Overall Survival Rate at 24 Months(At 24 Months)
- Overall Survival in Tumor Mutational Burden (TMB) High Population(From randomization to the date of death due to any cause (up to approximately 6 years))