NCT04634747尚未招募2 期
A Single-Arm, Open-Label, Multi-Center Phase II Study to Evaluate the Combination of PVX-410 + Pembrolizumab + Chemotherapy for Frontline Therapy of Metastatic, PD-L1+ Triple-Negative Breast Cancer (TNBC) in HLA-A2-Positive Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 53
- 主要终点
- Progression Free Survival
研究概览
简要总结
Evaluating the combination of the investigational, multi-peptide cancer vaccine PVX-410 in combination with pembrolizumab and chemotherapy in treatment naive patients with metastatic, triple negative breast cancer who are PDL1 and HLA A2 positive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •HLA A2 Positive PDL1 Positive Treatment naive, triple negative breast cancer
排除标准
- 未提供
研究组 & 干预措施
PVX-410/pembrolizumab/chemotherapy
Experimental
干预措施: PVX-410 (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 8 months
次要结局
未报告次要终点
研究者
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