EUCTR2016-004373-40-DE进行中（未招募）1 期
A phase II, open-label, multicenter trial to investigate the clinical activity and safety of avelumab in patients with advanced, metastatic high grade neuroendocrine carcinomas NEC G3 (WHO 2010) progressive after chemotherapy
niversity Medical Center of the Johannes Gutenberg-University Mainz0 个研究点目标入组 60 人开始时间: 2017年5月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •- Male or female patient = 18 years
- •- Histologically proven neuroendocrine neoplasia NEC G3 (WHO 2010)
- •- One block or 20 slides (4 microns) of archival tumor tissue to perform central pathological review and biomarker assessment
- •- No curative option available
- •- Progressive disease within 9 months before study initiation and after prior at least
- •one chemotherapy (platinum based chemotherapy or STZ/TEM/DTIC based
- •chemotherapy in NET G3)
- •- Presence of measurable disease as per RECIST1.1 criteria
- •- ECOG Performance Status 0 – 2
- •- Written informed consent
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Merkel Cell carcinoma (MCC) or small cell lung cancer (SCLC)
- •- Typical or Atypical Carcinoid of the lung with a Ki67 < 20%
- •- Prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints)
- •- Neuroendocrine tumors that are potentially curable by surgery
- •- Major surgery within 4 weeks of first dose of study medication.
- •- TACE, TAE, SIRT or PRRT within 3 months of starting study treatment
- •- Patients pretreated with Interferon as last treatment line prior to study entry
- •- Concurrent anticancer treatment
- •- active infection requiring systemic therapy including, HIV/AIDS, HBV or HCV
- •- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- •- Pregnancy or lactation
- •- Vaccination within 4 weeks of the first dose of avelumab and while on trial
研究者
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