A Multicenter Phase II Open Label Study to Evaluate Efficacy of Concomitant Use of Pembrolizumab and Entinostat in Adult Patients With Metastatic Uveal Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to see if the combination of entinostat and pembrolizumab can be an effective treatment for patients with melanoma of the eye (uveal melanoma) that has spread to other sites of the body (metastatic disease). Pembrolizumab is an antibody that helps the immune system to attack cancer cells. Although pembrolizumab has proven clinical efficacy in treating patients with metastatic cutaneous melanoma, an effect on metastatic uveal melanoma has not been established. Entinostat is a histone deacetylase (HDAC) inhibitor that has effects on both cancer cells and immune regulatory cells, thus potentially enhancing the effects of immunotherapy.
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
- •Age above 18 years.
- •Signed and dated written informed consent before the start of specific protocol procedures.
- •ECOG PS 0-1
- •Histologically/cytologically confirmed stage IV uveal melanoma
- •Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
- •Any number of prior therapies (including none), with the exception of anticancer immunotherapy
排除标准
- •Active brain metastases (symptomatic and/or requiring corticosteroids) or leptomeningeal metastases
- •Previous treatment with anticancer immunotherapy
- •Pregnant or nursing (lactating) women
- •Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
- •Active autoimmune disease
- •Immune deficiency or treatment with systemic corticosteroids
- •Use of other investigational drugs (drugs not marketed for any indication) within 28 days before study drug administration
- •Life expectancy of less than 3 months
研究组 & 干预措施
Pembrolizumab and Entinostat
干预措施: Pembrolizumab (Drug)
Pembrolizumab and Entinostat
干预措施: Entinostat (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From first dose up to 24 months
The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1.
次要结局
- Progression free survival (PFS)(From first dose up to 24 months)
- Overall Survival (OS)(From first dose up to 24 months)
- Best overall response (BOR)(From first dose up to 24 months)
- Clinical benefit rate (CBR)(18 weeks from first dose)
- Duration of objective response (DOR)(From first dose up to 24 months)
- Quality of Life (QoL) assessed by FACT-G(From first dose up to 24 months)
- Time To Response (TTR)(From first dose up to 24 months)
- Adverse Events (AEs) and Serious Adverse Events (SAEs).(From first dose up to 24 months)
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS)(18 weeks from first dose)
- Quality of Life (QoL) assessed by EQ5D-3L(From first dose up to 24 months)