Phase II Study to Evaluate the Safety, Tolerability and Efficacy of CT-011 Administered Intravenously to Patients With Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 18
- 主要终点
- The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011
研究概览
简要总结
The purpose of this research study is to see if the study drug, CT-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. CT-011 is a monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab instead of by the immune system which then recruit the immune system to help fight cancer cells.
All final eligible subjects will receive an intravenous infusion of CT-011. This study will test two dose levels of the study drug:
Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg).
Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg).
Each group will be given the study drug through an IV (a needle put into a vein in the arm) on day 1. After day 1, the study drug will be given every other week. Patients may be given a total of up to 27 study drug infusions for about 12 months while they are in the study. Approximately 100 patients will participate in this study.
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
- •Participants must have a histologically or cytologically documented diagnosis of metastatic melanoma.
- •Participants age is 18 years or older.
- •Stage IV disease that is clearly progressive since last therapy
- •ECOG performance status of 0 or 1.
排除标准
- •Patients with uveal melanoma.
- •Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (eg: + ANA, +RF, antithyroglobulin antibodies) or mild arthritis requiring no therapy or manageable with NSAIDs.
- •Prior use of anti PD-1, anti PD-L1 or PD-L2 therapy.
- •More than 3 prior lines of treatment for metastatic melanoma including approved and investigational treatments.
- •Women of child bearing potential who are pregnant
- •Note: This is only a partial list of eligibility criteria.
研究组 & 干预措施
CT-011 at dose level 1 (1.5 mg/kg).
干预措施: CT-011 (Drug)
CT-011 at dose level 2 (6 mg/kg).
干预措施: CT-011 (Drug)
结局指标
主要结局
The objective response rate (ORR) by Immune Related Response Criteria (irRC) in patients with metastatic melanoma treated with CT-011
时间窗: Approximately 28 months
次要结局
- Safety of CT-011(Approximately 28 months)
- Progression Free Survival by Immune Related Response Criteria(Approximately 28 months)
- Overall Survival(Approximately 28 months)