A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 14
- 主要终点
- Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria
研究概览
简要总结
To assess the response of melanoma with brain metastases to ipilimumab treatment while maintaining acceptable tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ipilimumab, 10 mg/kg, IV in corticosteroid-free patients
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.
干预措施: Ipilimumab (Drug)
Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients
Participants who were dependent on corticosteroid therapy received ipilimumab, 10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria
时间窗: From Day 1, first dose to end of Week 12
Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system.
次要结局
- Disease Control Rate by Immune-related Response Criteria (irRC)(From Day 1, first dose to end of Week 12)
- Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)(From Day 1, first dose to the date of progression or death, whichever occurred first up to 22 months)
- Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)(From Day 1, first dose until the last tumor assessment, Week 12)
- Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC)(From Day 1, first dose to a maximum of 4.2 months)
- Overall Survival (OS)(From first dose to 24 months)
- Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)(From Day 1, first dose to last tumor assessment up to 18.2 months)
- Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)(From first dose to Months 6, 12, 18, 24, and 36 months)
- Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation(Continuously from Day 1, first dose, to 70 days following last dose of ipilimumab)