EUCTR2015-003589-10-RO进行中（未招募）1 期
A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination with Tremelimumab versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients - KESTRE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 823
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
- •1. Age =18 years at the time of screening
- •2. Documented evidence of SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).
- •3. A fresh tumor biopsy for the purpose of screening or an available archival
- •tumor sample.
- •4. No prior systemic chemotherapy for recurrent or metastatic disease
- •5. World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment
- •6. No prior exposure to immune-mediated therapy
- •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 376
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 252
排除标准
- •1. Received any systemic therapy for recurrent or metastatic SCCHN
- •2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
- •3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
- •4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn’s disease], diverticulitis
研究者
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