An Open-label, Phase II Study of Durvalumab (MEDI4736) in Combination With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Objective response rate
研究概览
简要总结
The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.
详细描述
This research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight > 30 kg
- •Histologically or cytologically confirmed recurrent or metastatic HNSCC
- •Not considered a candidate for other curative therapy (i.e. surgery/RT)
- •Documented progression of disease after receiving platinum based regimen
- •ECOG performance status 0-2
排除标准
- •Nasopharyngeal and salivary gland tumors
- •Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.
研究组 & 干预措施
Durvalumab and Cetuximab
Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance
干预措施: Durvalumab (Drug)
Durvalumab and Cetuximab
Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance
干预措施: Cetuximab (Drug)
结局指标
主要结局
Objective response rate
时间窗: 24 months
Imaging review using RECIST 1.1
次要结局
- Overall survival(24 months)
- Duration of response(24 months)
- Progression-free survival(24 months)
- Adverse events(24 months)
- Disease control rate(6 months)
- Treatment Related Adverse Events(From informed consent through study treatment and the 90-day safety follow-up period after the last dose of durvalumab and cetuximab, approximately 24.5 months.)
研究者
Trisha Wise-Draper
Principal Investigator
University of Cincinnati