EUCTR2014-003698-41-NL进行中（未招募）1 期
A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.0 个研究点目标入组 780 人开始时间: 2015年2月5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
- 780
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
- •Have histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapies.
- •Have measurable disease based on RECIST 1.1 as determined by the site.
- •Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •Have results from local testing of HPV positivity for oropharyngeal cancer defined as p16 IHC testing using CINtec® p16 Histology assay and a 70% cut off point.
- •Have provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy.
- •(600 subjects with any PD-L1 result will be enrolled first followed by 180 subjects who must have strongly positive PD-L1 expression)
- •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 620
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •Has disease that is suitable for local therapy administered with curative intent.
- •Has progressive disease within six months of completion of curatively intended treatment for locoregionally advanced HNSCC.
- •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 prior malignancy with recurrence in the last 5 years.
- •Active autoimmune disease that has required systemic treatment in past 2 years.
- •Has evidence of active, non-infectious pneumonitis.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or if the patient has previously participated in Merck MK-3475 clinical trials.
- •Has an active infection requiring systemic therapy.
- •Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to randomization or not fully recovered from AE due to previous treatment
研究者
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