A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects With Previously Treated Unresectable Stage III or IV Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 11
- 主要终点
- Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate
研究概览
简要总结
The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Subjects must have been previously treated with one line of systemic anti-cancer therapy (non-experimental or experimental) for metastatic disease, and relapsed, failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has been administered as an adjuvant and/or neoadjuvant therapy, the subject must have documented disease progression from the last treatment and also received one additional line of systemic therapy for metastatic disease.
- •Men and women, who are at least 18 years of age
排除标准
- •Ocular or mucosal melanoma
- •Complete surgical resection of all identifiable sites of disease
- •Symptomatic brain metastasis. Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by computerized axial tomography (CT) scan or magnetic resonance imaging (MRI). Subjects with stable brain metastasis and those who were previously treated with radiotherapy or surgery must have no current evidence of symptomatic brain metastasis and are off steroid therapy for at least 4 weeks prior to randomization
研究组 & 干预措施
Arm 1
0.1 mg/kg every 3 weeks
干预措施: Anti-CD137 (4-1BB) (BMS-663513) (Drug)
Arm 2
1 mg/kg every 3 weeks
干预措施: Anti-CD137 (4-1BB) (BMS-663513) (Drug)
Arm 3
1 mg/kg every 6 weeks
干预措施: Anti-CD137 (4-1BB) (BMS-663513) (Drug)
Arm 4
5 mg/kg every 3 weeks
干预措施: Anti-CD137 (4-1BB) (BMS-663513) (Drug)
结局指标
主要结局
Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate
时间窗: every 6 weeks starting at week 12 after randomization
次要结局
- Biomarkers(throughout the study)
- Safety profiles(throughout the study)
- Disease response rate(end of study)
- Disease control rate(end of study)
- 1-year survival(end of study)
- Pharmacokinetics(throughout the study)
- Pharmacodynamics(throughout the study)