A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment Versus Chemotherapy for Subjects With Advanced Melanoma Who Progressed After Initially Achieving Disease Control With Ipilimumab Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 8
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.
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
- •Histologic diagnosis of unresectable stage III or IV metastatic melanoma
- •Prior ipilimumab induction treatment (3 mg/kg)
- •Documented disease control [Stable Disease ≥3 months or Partial Response/Complete Response] after ipilimumab induction
- •Documented progressive disease following disease control
排除标准
- •Patients with brain metastasis are excluded, unless they are free of neurologic symptoms related to metastatic brain lesions and do not receive systemic corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10 days prior to beginning retreatment with ipilimumab
- •Any intervening anticancer therapy between last dose of ipilimumab induction and ipilimumab retreatment on study
- •Patients who experienced any grade 3 immune-related adverse event (irAE) (except for endocrinopathies where clinical symptoms were controlled with appropriate hormone replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab
- •Patients with a prior irAE that has not improved to grade 1 or better at randomization
研究组 & 干预措施
Ipilimumab, 3 mg/kg
Participants received ipilimumab, 3 mg/kg, by intravenous infusion, every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
干预措施: Ipilimumab (Biological)
Chemotherapy
Participants received the investigator's choice of chemotherapy, administered per package instructions.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization to death or last known alive date, assessed up to 15.6 months
Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)
次要结局
- Disease Control Rate (DCR)(Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease)
- Best Overall Response Rate (BORR)(Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease)