EUCTR2014-000445-79-ES进行中（未招募）1 期
A Phase II, open-label, multicenter trial to investigate the clinical activity and safety of MSB0010718C in subjects with Merkel cellcarcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Signed written informed consent
- •? Age 18 years and above
- •? Histologically proven MCC as defined in the protocol
- •? Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •? Adequate hematological, hepatic and renal function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •? Prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-programmed death 1 (PD-1), anti-programmed death ligand 1 (anti-PD-L1), or anticytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody
- •? Subjects with active central nervous system (CNS) metastases are excluded. Subjects with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 2 months, and do not require continued steroid therapy
- •? Previous malignant disease (other than MCC) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ
- •? Significant acute or chronic infections (among others, positive test for human immunodeficiency virus [HIV] 1/2) or known acquired immunodeficiency syndrome or with active or history of any hepatitis)
- •? Active or history of any autoimmune disease (except for subjects with vitiligo) or immunodeficiencies that required treatment with systemic immunosuppressive drugs
- •? Known severe hypersensitivity reactions to monoclonal antibodies (Grade greater than or equal to [>=] 3 NCI-CTCAE Version 4.0), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
研究者
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