EUCTR2015-003589-10-IT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
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
- 760
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 recurrent or metastatic 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 Systemic therapy given as part of multimodality treatment for locally advanced or locally recurrent disease is allowed
- •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 456
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 304
排除标准
- •1. Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland)
- •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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