EUCTR2021-000986-34-DE进行中（未招募）1 期
A phase II, open-label, multicenter trial to investigate the clinical activity and safety of Cabozantinib in combination with avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3). - CaboAveNEC
niversity Medical Center of the Johannes Gutenberg-University Mainz0 个研究点目标入组 30 人开始时间: 2021年9月1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
- 30
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
- •- Age = 18 years
- •- Histologically proven neuroendocrine neoplasia NEN G3 (WHO 2010/2019)
- •- One block or 20 slides (4 microns) of archival tumor tissue to perform central pathological review and biomarker assessment and for translational research
- •- No curative option available
- •- Progression after at least one chemotherapy (platinum based or STZ/TEM/DTIC based chemotherapy)
- •- Presence of measurable disease as per RECIST1.1 criteria
- •- Adequate organ and bone marrow function
- •- ECOG Performance Status 0 – 1
- •- 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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
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 TKI or immune therapy
- •- Neuroendocrine tumors that are potentially curable by surgery
- •- Major surgery within 4 weeks before first dose of study medication. Complete wound
- •healing must be observed at least 10 days prior to enrollment.
- •- Patients who are at increased risk for severe haemorrhage
- •- TACE, TAE, SIRT or PRRT within 8 weeks before first dose of study medication
- •- Patients pretreated with Interferon as last treatment line prior to study entry
- •- Concurrent anticancer treatment
- •- Active infection requiring systemic therapy including, HIV/AIDS, HBV, HCV, Covid 19
- •- Severe active autoimmune disease that requires immunomodulatory therapy
- •- Uncontrolled hypertension
- •- Congestive heart failure or symptomatic coronary artery disease
- •- Pregnancy or lactation
- •- Vaccination within 4 weeks before the first dose of avelumab and while on trial
研究者
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