A Randomized Phase II Clinical Trial Assessing the Efficacy and Safety of MK-3475 (Pembrolizumab) in Combination With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 87
- 试验地点
- 6
- 主要终点
- Objective Response Rate
研究概览
简要总结
The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic triple negative breast cancer.
Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells. Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and metastatic non-small cell lung cancer. However, it has not been approved as a treatment for breast cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pembrolizumab with Standard Chemotherapy
Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine.
干预措施: Pembrolizumab (Drug)
Pembrolizumab with Standard Chemotherapy
Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine.
干预措施: Carboplatin (Drug)
Pembrolizumab with Standard Chemotherapy
Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine.
干预措施: Gemcitabine (Drug)
Standard Chemotherapy Alone
Standard chemotherapy alone using carboplatin and gemcitabine.
干预措施: Carboplatin (Drug)
Standard Chemotherapy Alone
Standard chemotherapy alone using carboplatin and gemcitabine.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Up to 24 months
Evaluate antitumor activity by assessing the percentage of patients with evidence of complete response or partial response per RECIST 1.1 criteria.
Incidence of Treatment-Related Adverse Events
时间窗: From the first dose of study treatment until 30 days after discontinuation of study treatment.
The safety and tolerability of Pembrolizumab in Combination with Carboplatin and Gemcitabine will be evaluated from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results.
次要结局
- Progression Free Survival(From the start of treatment until progressive disease or date of death, whichever occurs first (assessed up to 60 months.))
- Overall Survival(From the start of treatment until death (assessed up to 60 months.))
- Clinical Benefit Rate(Up to 24 months)