JPRN-UMIN000026497已完成1 期
Phase I trial of nivolumab in pediatric patients with malignant solid tumors or Hodgkin lymphoma - Phase I trial of nivolumab in pediatric patients with malignant solid tumors or Hodgkin lymphoma (PENGUIN trial)
ational Cancer Center0 个研究点目标入组 26 人开始时间: 2017年3月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
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
- 1years-old 至 24years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Active double cancer (except for completely resected basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, intramucosal cancer, superficial bladder cancer, gastrointestinal cancer resected by ESD or EMR, and other cancer free of relapse for more than 5 years) 2)Infection requiring systemic therapy 3)Active gastrointestinal ulceration 4)Current or previous pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings (except for inactive scar or fibrosis associated with radiotherapy) 5)Current or previous severe hypersensitive reaction to medicines 6)Currently active or previously chronic or recurrent auto immune disease (except for type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin disorder requiring no systemic therapy, and any auto immune disease expected not to relapse without external factors) 7)HIV antibody-positive, or HTLV-1 antibody-positive, or HBs antigen-positive, or HCV antibody-positive (except for HCV-RNA-negative even if HCV antibody-positive) 8)Though HBs antigen-negative, HBs antibody-positive and/or HBc antibody-positive, and HBV-DNA quantitative test positive 9)Pregnant or breast-feeding women, or women suspected of being pregnant 10)Psychiatric diseases or psychological symptoms interfering with participation in the trial
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