Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 47
- 主要终点
- Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)
研究概览
简要总结
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 < 18 years of age
- •Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma
- •Karnofsky Performance Status (KPS) or Lansky Score ≥ 50
排除标准
- •Primary Ocular Melanoma
- •Prior therapy with a Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) or Programmed death- 1 (PD-1) antagonist, or Programmed cell death- ligand 1 (PD-L1) or CD137 agonists
- •Symptomatic brain metastases
- •History of autoimmune diseases
研究组 & 干预措施
Ipilimumab 10 mg/kg
Ipilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
干预措施: Ipilimumab (Biological)
Ipilimumab 3 mg/kg
Ipilimumab (3 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
干预措施: Ipilimumab (Biological)
结局指标
主要结局
Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)
时间窗: From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months)
The percentage of participants with severe Immune-mediated Adverse Reactions (imARs) was determined by dividing the number of participants with grade 3 or worse imARs by the total number of treated participants and expressing this number as a percentage. imARs were AEs determined by the investigator to have an immune-mediated etiology, including inflammatory events associated with ipilimumab treatment.
Overall Survival (OS) Rate at 1 Year
时间窗: 1 year following start of treatment (Assessed up to June 2016, approximately 38 months)
Overall Survival (OS) was defined as the time from the start of ipilimumab treatment date to death due to any cause. If a participant had not died, the participant was censored at the time of last contact (last known alive date). OS rates at 1 year were calculated from both Kaplan-Meier estimates and the proportion of participants alive at 1 year following start of treatment.
次要结局
- Overall Survival Time(From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months))
- Disease Control Rate (DCR)(From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months))
- Best Overall Response Rate (BORR)(From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months))
- Progression Free Survival(From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months))