NCT03425565进行中（未招募）2 期
A Phase II Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Progression Free Survival at 12 weeks
研究概览
简要总结
PEACOCC is a multi-centre, single arm, single stage phase II trial. The overall aim is to determine whether treatment with pembrolizumab is effective in patients with advanced clear cell gynaecological cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of advanced clear cell ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval or cervical cancer.
- •Have measurable disease based on RECIST 1.
- •Evidence of radiological disease progression.
- •Patient is willing to provide tissue from a newly obtained core or excisional biopsy of a tumour lesion at baseline, 6-8 weeks after start of treatment and at the time of progression.
- •ECOG Performance Status 0 or
- •Patient has a life expectancy of at least 3 months from consent.
- •Received ≥ 1 line of prior chemotherapy .
排除标准
- •Has a known diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses > 10mg prednisolone daily or equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •Has a known history of active TB (Bacillus Tuberculosis), Hepatitis B (e.g., HBsAg reactive), Hepatitis C or a known history of Human Immunodeficiency Virus (HIV).
- •Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids (at a dose >10mg predisolone daily or equivalent) or immunosuppressive drugs).
- •Has known history or evidence of active, non-infectious pneumonitis.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- •Has received a live vaccine within 30 days prior to the planned start of trial treatment.
研究组 & 干预措施
Pembrolizumab
Experimental
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Progression Free Survival at 12 weeks
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
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