Phase 2 Study of Ipilimumab in Japanese Subjects With Unresectable or Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
研究概览
简要总结
The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of malignant melanoma
- •Previously-treated or untreated unresectable Stage III or Stage IV melanoma
- •Measurable/evaluable disease per modified World Health Organization (mWHO) criteria, within 28 days of first dose of study drug
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Active brain metastases
- •Primary ocular or mucosal melanoma
- •History of or current active autoimmune disease
结局指标
主要结局
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
时间窗: Day 1 to 90 Days after the last dose, up to May 2014
AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Primary endpoint (PE) includes results from Day 1 to 12 weeks after initial dose of last participant. Data evaluated at PE last patient, last visit (LPLV).
次要结局
- Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants(Day 1 to 90 Days after the last dose, up to July 2014)
- Number of Participants With Liver Function Laboratory Abnormalities(Baseline to 90 days post last dose, up to July 2014)
- Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response(Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years))
- Number of Participants With Hematology Laboratory Abnormalities(Baseline to 90 days post last dose, up to July 2014)
- Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response(Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years))
- Number of Participants Who Died - All Treated Participants(Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years))
- Number of Participants With Renal Laboratory Abnormalities(Baseline to 90 days post last dose, up to July 2014)