NCT03199872已完成1 期
A Phase I/II Study of RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- RhoVac APS
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Proportions of Participants With Treatment-related Adverse Events
研究概览
简要总结
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients prostatectomised (PT) due to histologically verified adenocarcinoma of the prostate gland who currently are not being treated, or expected within the next 8 months to be treated, with any anti-cancer treatment.
- •ECOG performance status 0 or 1.
排除标准
- •Patient has been treated with Androgen Deprivation Therapy (ADT), or expected to receive such treatment within the next 8 months from enrolment.
- •Severe medical conditions, such as but not limited to severe asthma/chronic obstructive pulmonary disease (COPD), New York Heart Association (NYHA) grading 3 or above, poorly regulated insulin dependent diabetes, any significant organ damage as judged by the Investigator.
结局指标
主要结局
Proportions of Participants With Treatment-related Adverse Events
时间窗: 8 month
Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- Immunological Response(12 months)
研究者
研究点 (2)
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