NCT00803374撤回1 期
A Phase I, Multiple Ascending Dose Study of BMS-663513 (Anti CD137) in Combination With Ipilimumab (BMS-734016/Anti-CTLA-4) in Subjects With Unresectable Stage III or Stage IV Melanoma
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests
研究概览
简要总结
The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable
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
- •Histologically or cytologically confirmed malignant melanoma
- •Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
- •Willing to undergo up to 3 biopsies of an accessible lesion
排除标准
- •Active/symptomatic brain metastases
- •Primary ocular melanoma or primary tumor of unknown origin
- •Concurrent autoimmune disease
- •Previous treatment with a CD137 agonist or CTLA-4 inhibitor
研究组 & 干预措施
0.3 mg/kg
Experimental
干预措施: AntiCD137 (Drug)
0.3 mg/kg
Experimental
干预措施: Ipilimumab (Drug)
0.1 mg/kg
Experimental
干预措施: AntiCD137 (Drug)
0.1 mg/kg
Experimental
干预措施: Ipilimumab (Drug)
1.0 mg/kg
Experimental
干预措施: AntiCD137 (Drug)
1.0 mg/kg
Experimental
干预措施: Ipilimumab (Drug)
3.0 mg/kg
Experimental
干预措施: AntiCD137 (Drug)
3.0 mg/kg
Experimental
干预措施: Ipilimumab (Drug)
10 mg/kg
Experimental
干预措施: AntiCD137 (Drug)
10 mg/kg
Experimental
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests
时间窗: During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received
次要结局
- Evidence of clinical improvement in tumor burden confirmed by CT or MRI(Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter)
研究者
研究点 (1)
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