NCT01489059已完成1 期
A Phase I Dose Escalation Study of BMS-982470 (Recombinant Interleukin 21, rIL-21) in Combination With Ipilimumab in Subjects With Unresectable Stage III or Stage IV Melanoma
Bristol-Myers Squibb18 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2011年12月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 18
- 主要终点
- Part1 (Dose Escalation): The Maximum tolerated dose (MTD) of BMS-982470 using 2 distinct schedules when administered in combination with Ipilimumab
研究概览
简要总结
The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone
详细描述
Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Unresectable Stage III or Stage IV melanoma
- •Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Programmed Death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2 or anti-CD137
- •Part 2 Cohort expansion: Prior treatment for melanoma is not allowed, except for adjuvant therapy with interferon alpha or melanoma vaccines which are permitted
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
- •Normal liver function tests
排除标准
- •Part 1 Dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks post-radiation treatment, and off steroids are allowed
- •Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded
- •Autoimmune disease
结局指标
主要结局
Part1 (Dose Escalation): The Maximum tolerated dose (MTD) of BMS-982470 using 2 distinct schedules when administered in combination with Ipilimumab
时间窗: Within the first 63 days
Based on the dose-limiting toxicity (DLT) rate
Part 2 (Cohort Escalation): Safety and tolerability of the MTD dose for each of the schedules
时间窗: 84 days on treatment
Based on medical review of AE reports and the results of vital sign measurements, physical examinations, medical history, and clinical laboratory tests
次要结局
- Area under the serum concentration-time curve from time zero to the last quantifiable concentration [AUC(0-T)] of BMS-982470 and Ipilimumab(20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3)
- Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] of BMS-982470 and Ipilimumab(20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3)
- Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-982470 and Ipilimumab(20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3)
- The maximum observed serum concentration (Cmax) of BMS-982470 and Ipilimumab(20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3)
- Efficacy of BMS-982470 in combination with Ipilimumab as measured by objective response(Baseline (Day 1), End of Treatment (EOT) [3 weeks after last dose of Ipilimumab], 3 and 6 months Follow-up)
- Trough observed serum concentration (Cmin) of BMS-982470 and Ipilimumab(1 time point each 3-week Cycle)
- The time of maximum observed serum concentration (Tmax) of BMS-982470 and Ipilimumab(20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3)
- Serum half-life (T-HALF) of BMS-982470 and Ipilimumab(20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3)
- Apparent total body clearance (CLT) of BMS-982470 and Ipilimumab(20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3)
- Apparent volume of distribution at steady state (Vss) of BMS-982470 and Ipilimumab(20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3)
- Incidence of BMS-984270 and Ipilimumab Anti-Drug Antibodies(Up to 6 months following last dose)
研究者
研究点 (18)
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