NCT04393753已完成2 期
A Phase II, Open Label Study to Investigate the Efficacy and Safety of Domatinostat in Combination With Avelumab in Patients With Advanced Unresectable/Metastatic Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 Antibody Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 4SC AG
- 入组人数
- 19
- 试验地点
- 22
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell Carcinoma that have progressed on a previous therapy with an anti-PD-(L)1 antibody
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
- •Histologically confirmed Merkel Cell Carcinoma (MCC)
- •ECOG performance status ≤ 1
- •MCC in an advanced, unresectable stage III or metastatic stage IV (includes patients who refused surgical resection or are not eligible for such surgical resection)
- •Progressing on previous anti-PD-(L)1 antibody monotherapy within the last 12 weeks before planned first administration of study medication
排除标准
- •History of serious anti-PD-(L)1 therapy-related adverse reactions prohibiting further avelumab treatment
- •More than one line of previous systemic anti-neoplastic therapy other than anti-PD-(L)1 antibody monotherapy
- •Palliative radiation therapy of single lesions within 2 weeks before planned administration of study medication
- •Presence of significant active or chronic disease (infections, immunodeficiencies, cardiovascular, psychiatric disorders)
研究组 & 干预措施
domatinostat and avelumab
Experimental
Single arm study of Domatinostat tablets in combination with avelumab infusion
干预措施: domatinostat in combination with avelumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 24 months
Objective Response Rate (ORR) defined as the percentage of patients having a confirmed CR or PR according to RECIST v1.1
次要结局
- Durable Response Rate (DRR)(up to 24 months)
- Duration of Response (DoR)(up to 24 months)
- Disease Control Rate (DCR)(up to 24 months)
- Durable Disease Control Rate (dDCR)(up to 24 months)
- Best Overall response (BOR)(up to 24 months)
- Overall Survival (OS)(up to 36 months)
- OS Rate(up to 12 months)
- Progression Free Survival (PFS)(up to 24 months)
- PFS Rate(up to 24 months)
- Safety and Tolerability(up to 24 months)
- Health related Quality of Life (HrQoL)(up to 24 months)
- Plasma concentration of domatinostat and avelumab(up to 48 weeks)
- Avelumab anti-drug antibodies (ADA)(up to 48 weeks)
研究者
研究点 (22)
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