NCT02545075已完成3 期
A Randomized, Open-Label, Two-arm, Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2015年10月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Two-Years Survival Rate
研究概览
简要总结
The purpose of this study is to determine whether Ipilimumab will extend the life of chinese patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to examine safety in this patient population.
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
- •Chinese males and females ≥ 18 years of age
- •Histologic diagnosis of malignant melanoma
- •Chemotherapy naive Stage IV melanoma (AJCC 2010)
- •Life expectancy of ≥ 16 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Evidence of brain metastases on brain imaging
- •Primary ocular or mucosal melanoma
- •Any other malignancy from which the patient has been disease-free for less than 5 years
- •BRAF status cannot be determined by Screening test
- •Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen (HBsAg) positive, or active Hepatitis C infection
研究组 & 干预措施
Dacarbazine
Experimental
IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22)
干预措施: Dacarbazine (Drug)
Ipilimumab
Experimental
Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Two-Years Survival Rate
时间窗: 24 months
Two-year survival rate is defined as the probability that a subject is alive at 2 years following the randomization date and will be estimated via the Kaplan-Meier (KM) method.
次要结局
- Overall Survival (OS)(Approximately 43 months)
- One-Year Survival Rate(Approximately 43 months)
- Progression Free Survival ( PFS)(Approximately 43 months)
- Disease Control Rate ( DCR )(Approximately 43 months)
- Best Overall Response Rate ( BORR )(Approximately 43 months)
- Duration of Response ( DoR)(Approximately 43 months)
- Duration of Stable Disease ( DoSD )(Approximately 43 months)
研究者
研究点 (1)
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