NCT00289627已完成2 期
A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
研究概览
简要总结
The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.
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
- •Patients with previously treated Stage III (unresectable)or Stage IV melanoma
排除标准
- 未提供
研究组 & 干预措施
ipilimumab (MDX-010, BMS-734016)
Experimental
干预措施: ipilimumab (MDX-010, BMS-734016) (Drug)
结局指标
主要结局
Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
次要结局
- estimate disease control rate
- estimate progression free survival rate at Week 12
- estimate PFS
- estimate overall survival
- estimate survival rate at one year
- estimate duration of BOR
- evaluate proportion of patients whose duration of response is >=24 weeks
- estimate time to BOR
- evaluate safety profile of ipilimumab during the induction and maintenance phases
- evaluate health-related quality of life
- obtain PK sample for population PK analysis
研究者
研究点 (1)
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相似试验
已完成
2 期
Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV MelanomaMelanomaNCT00289640Bristol-Myers Squibb210
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A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV Melanoma.Revised Protocol 01, incorporating Amendment 02; and Pharmacogenetics Blood Sample Amendment #01, version 1.0 dated 01-Jul-05, Pharmacogenomics Archived Tissue Sample Amendment #03, version 1 dated 29-Mar-06 and Pharmacogenomic Biomarker Sample Amendment #04, version 1 dated 03-Apr-06.MelanomaEUCTR2005-002051-41-SEBristol-Myers Squibb International Corporation170
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A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV MelanomaRevised Protocol 01, incorporating Amendment 02Estudio multicéntrico, fase II, de un solo brazo de tratamiento con MDX-010 (BMS734016) en monoterapia en pacientes con melanoma Estadio III o IV previamente tratadoMelanomaEUCTR2005-002051-41-ESBristol-Myers Squibb International Corporation170
进行中（未招募）
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A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV Melanoma.Revised Protocol 01, incorporating Amendment 02; and Pharmacogenetics Blood Sample Amendment #01, version 1.0 dated 01-Jul-05, Pharmacogenomics Archived Tissue Sample Amendment #03, version 1 dated 29-Mar-06 and Pharmacogenomic Biomarker Sample Amendment #04, version 1 dated 03-Apr-06.MelanomaEUCTR2005-002051-41-NOBristol-Myers Squibb International Corporation170
进行中（未招募）
不适用
A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV Melanoma.Revised Protocol 02, incorporating Amendment 06, Administrative Letter 01, 02, and 03; and Pharmacogenetics Blood Sample Amendment #01, version 1.0 dated 01-Jul-05, Pharmacogenomics Archived Tissue Sample Amendment #03, version 1 dated 29-Mar-06 and Pharmacogenomic Biomarker Sample Amendment #04, version 1 dated 03-Apr-06.MelanomaEUCTR2005-002051-41-ATBristol-Myers Squibb International Corporation170