NCT03538314已完成1 期
A Phase I, Open-label, Multicenter Study Investigating the Tolerability and Efficacy of UV1 Vaccine in First-line Malignant Melanoma Patients Planned for Treatment With Pembrolizumab
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Number of patients with treatment-related adverse events
研究概览
简要总结
UV1 is a therapeutic cancer vaccine that has been explored in prostate and lung cancers, and in combination with ipilimumab in malignant melanoma. This study will explore the safety, tolerability and efficacy of UV1 administered with GM-CSF in melanoma patients who are also receiving pembrolizumab.
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
- •Stage IIIB, IIIC or IV melanoma
- •Previously untreated and eligible for pembrolizumab treatment (prior treatment with BRAF and MEK inhibitors permitted) 3) Adequate blood, liver and kidney function 4) Consent to undergo tumor biopsies during the study
排除标准
- •Uveal or ocular malignant melanoma
- •History of hematologic or primary solid tumor malignancy with the exception of patients in remission for at least 5 years, as judged by the investigator are allowed
- •Prior systemic treatment for unresectable or metastatic melanoma. Exception: Prior treatment with BRAF and MEK inhibitors permitted. A washout period of at least 3-half-lives (median terminal half-life) prior to the first dose of trial treatment must have elapsed.
- •Prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, anti-PD-L2 agent or oncolytic virus.
- •Known hypersensitivity to GM-CSF
- •Women who are breastfeeding, pregnant or expect to be pregnant during the study through 6 months after the last dose
- •Men who plan to become a father during the study through 4 months after the last dose of study medication
- •Known history of, or any evidence of active, non-infectious pneumonitis
- •History of cardiac disease
研究组 & 干预措施
Experimental Treatment
Experimental
UV1/GM-CSF
干预措施: UV1 (Drug)
Experimental Treatment
Experimental
UV1/GM-CSF
干预措施: GM-CSF (Drug)
结局指标
主要结局
Number of patients with treatment-related adverse events
时间窗: Up to week 29
Frequency and severity of adverse events
次要结局
- The length of time from the start of treatment that patients are still alive.(up to 2 years)
- Tumor response(Up to week 52)
研究者
研究点 (4)
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