NL-OMON55474已完成2 期
A randomized, open-label phase II/III study with dendritic cells loaded with allogeneic tumour cell lysate (PheraLys) in subjects with mesothelioma as maintenance treatment (MesoPher) after chemotherapy - DENIM (DENdritic cell Immunotherapy for Mesothelioma)
Amphera B.V.0 个研究点目标入组 118 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Signed informed consent within 8 weeks of their last chemo and the date of
- •the informed consent must be such that it is possible to schedule the first
- •study treatment 9 to 13 weeks after their last chemo therapy.
- •- Histologically confirmed diagnosis of pleural malignant mesothelioma,
- •non-progressive after 4 to 6 cycles with first line chemotherapy with
- •antifolate/cisplatin (as determined by CT scanning)
- •- Measurable disease on CT scanning, by modified RECIST criteria or RECIST 1.1.
- •In absence of measurable disease a CT scan is needed to evaluate the disease.
- •- At least 18 years old
- •- WHO-ECOG performance status of 0 or 1
排除标准
- •- any concurrent medical, psychological or psychiatric disease or condition
- •that is likely to interfere with study procedures or results, or that in the
- •opinion of the investigator would constitute a hazard for participating in this
- •- serious intercurrent chronic or acute illness such as cardiac or hepatic
- •disease considered by the investigator to constitute an unwarranted high risk
- •for investigational dendritic cell treatment
- •- known active acute or chronic infection, including human immunodeficiency
- •virus (HIV) and hepatitis B or C
- •-history of autoimmune disease
- •-subjects with an organ allograft
研究者
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