NCT00135408已完成2 期
Randomized, Double-Blind, Placebo-Controlled Phase II Study Comparing the Safety of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide (Entocort EC) in Patients With Previously Treated Unresectable Stage III or IV Malignant Melanoma
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2005年12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
- 115
- 试验地点
- 1
- 主要终点
- Rate of Grade 2,3,4 Diarrhea - patients on study drug.
研究概览
简要总结
The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma)
- •Flexible Sigmoidoscopy and colonic biopsy required
排除标准
- •Patients with active, untreated central nervous system metastasis. Patients with autoimmune disease.
研究组 & 干预措施
A1
Active Comparator
干预措施: Ipilimumab+ Placebo (Drug)
A2
Active Comparator
干预措施: Ipilimumab+ Budesonide (Drug)
结局指标
主要结局
Rate of Grade 2,3,4 Diarrhea - patients on study drug.
次要结局
- Safety monitored w/follow-up period. Assess Best Objective response, Disease control rate, progression free survival, overall survival, duration/best objective response, Time/best objective response. PK, immunogenicity & pharmacodynamic analysis(at Week 24)
研究者
研究点 (1)
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