EUCTR2016-001645-64-CZ进行中（未招募）1 期
A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination with Ipilimumab versus Nivolumab in Combination with Ipilimumab Placebo In Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) - CheckMate 714
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 675
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
- •Confirmed squamous cell head and neck cancer Widespread (metastatic) disease, or returned after previous treatment (recurrent)
- •Tumor sample must be available for analysis of PDL1 and HPV (oropharynx only) Performance status (ECOG 0-1)
- •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 473
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 202
排除标准
- •Previous treatment of metastatic or recurrent disease
- •Cancer arising from one of the following primary sites: paranasal sinus,
- •nasopharynx, salivary gland, skin
- •Any non-squamous subtype
- •Active autoimmune disease
- •Positive test for hepatitis B, C or HIV virus
- •Previous treatment with checkpoint inhibitor drugs
- •Active CNS metastases or carcinomatous meningitis
研究者
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