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临床试验/NL-OMON42832
NL-OMON42832已完成不适用

ImmunoModulation by the Combination of Ipilimumab and nivolumab neoadjuvant to Surgery In advanced Or recurrent Head and Neck Carcinoma, (IMCISION), a phase-Ib/II trial. Subtitle: Hypoxia as a determinant for the effect of nivolumab with or without ipilimumab on intra-tumoral T cell capacity - Immunotherapy neoadjuvant to surgery in head and neck carcinoma (IMCISION)

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 32 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32

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

  • 1. No immunosuppressive medications prior study inclusion, adults age > 18 years, and
  • 2. Histologically confirmed T3-4N0-3M0 HNSCC (with soft tissue infiltration depth of * 1 cm) of the oral cavity, oropharynx, hypopharynx or supraglottic larynx, eligible for curative surgery as primary treatment or salvage surgery after failed (chemo)radiation.
  • 3. WHO 0-1

排除标准

  • - Distant metastasis
  • - Autoimmune disease
  • - A condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
  • - Prior systemic treatment with immunotherapy targeting T-cell costimulation or immune checkpoint pathways;
  • - Hepatitis B / C, HIV or (AIDS);
  • - Pregnant or nursing.

研究者

发起方
Antoni van Leeuwenhoek Ziekenhuis

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