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临床试验/NCT03147404
NCT03147404已完成2 期

SAMSUND MEDICAL CENTER

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2017年12月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
14
试验地点
1
主要终点
BEST OF RESPONSE

研究概览

简要总结

Phase II study of avelumab in metastatic gastronetro-pancreatic (GEP) neuroendocrine carcinoma (NEC, WHO grade 3) as second-line treatment after failing to etoposide+cisplatin: integration of genomic analysis to identify predictive molecular subtypes

详细描述

Each subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final contact. After a screening phase of up to 28 days, eligible subjects will receive treatment beginning on Day 1 of each 2-week dosing cycle for aveluumab. Treatment with aveluumab will continue until documented disease progression, unacceptable adverse event(s),intercurrent illness that prevents further administration of treatment, Investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure requirements, After the end of treatment, each subject will be followed for 30 days for adverse event monitoring (serious adverse events and events of clinical interest will be collected for 90 days after the end of treatment or 30 days after the end of treatment if the subject initiates new anticancer therapy, whichever is earlier). Subjects who discontinue after 24months of therapy for reasons other than disease progression or intolerability or who discontinue after attaining a CR may be eligible for up to one year of retreatment after they have experienced radiographic disease progression. Subjects who discontinue for reasons other than disease progression will have post-treatment follow-up for disease status until disease progression, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to follow-up. All subjects will be followed by telephone for overall survival until death, withdrawal of consent, or the end of the study.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be willing and able to provide written informed consent/assent for the trial. The subject may also provide consent for Biomedical Research. However, the subject may participate in the main trial without participating in Biomedical Research.
  • Be20 years of age on day of signing informed consent
  • Have histologically or cytologically-confirmed diagnosis of GEP-NECs including all gastrointestinal tracts
  • Have metastatic disease or locally advanced, unresectable disease with feasible biopsy sites (baseline and follow up)
  • Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing any platinum/etoposide
  • Have measurable disease based on mRECIST as determined by investigator. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

排除标准

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Has grade 1 or 2 neuroendocrine tumor in GI tracts.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has a known history of active TB
  • Hypersensitivity to avelumab or any of its excipients.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.

研究组 & 干预措施

Avelumab

Experimental

Avelumab 10 mg/kg i.v. every 2 weeks (Q2W)

干预措施: Avelumab (Drug)

结局指标

主要结局

BEST OF RESPONSE

时间窗: 12months

次要结局

  • OVERALL RESPONSE(24months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seung tae Kim

Samsung Medical Center

Samsung Medical Center

研究点 (1)

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