A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination With Tremelimumab in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 24
- 主要终点
- Number of subjects experiencing dose-limiting toxicities
研究概览
简要总结
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects
- •18 years and older
- •Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) that is incurable by local therapy.
- •Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1 required) in the recurrent/metastatic setting.
- •Subject eligibility will be based on PD-L1 expression as determined by a specified IHC assay.
排除标准
- •Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days
- •Concurrent or prior use of immunosuppressive medication within 14 days
- •Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.
研究组 & 干预措施
MEDI4736 + tremelimumab
干预措施: MEDI4736 (Biological)
MEDI4736 + tremelimumab
干预措施: tremelimumab (Biological)
结局指标
主要结局
Number of subjects experiencing dose-limiting toxicities
时间窗: First dose of study medications through 4 weeks after the first dose of study medication
Change from Baseline in laboratory evaluations
时间窗: Screening through 3 months after the last dose of study medication
Number of subjects reporting serious adverse events
时间窗: Screening through 3 months after the last dose of study medication
Change from Baseline in electrocardiograms
时间窗: Screening through 3 months through last dose of study medication
Number of subjects reporting adverse events
时间窗: Screening through 3 months after the last dose of study medication
Change from Baseline in vital signs
时间窗: Screening through 3 months after the last dose of study medication
次要结局
- Objective Response Rate(Screening through 5 years after the last subject receives the first dose of study medication)
- Individual MEDI4736 concentrations(First dose of MEDI4736 through 3 months after the last dose of study medication)
- Duration of Response(Screening through 5 years after the last subject receives the first dose of study medication)
- MEDI4736 area under the concentration-curve(First dose of MEDI4736 through 3 months after the last dose of study medication)
- Tremelimumab area under the concentration-curve(First dose of tremelimumb through 3 months after the last dose of study medication)
- Progression Free Survival(Screening through 5 years after the last subject receives the first dose of study medication)
- Overall Survival(Screening through 5 years after the last subject receives the first dose of study medication)
- Individual tremelimumab concentrations(First dose of tremelimumab through 3 months after the last dose of study medication)
- Number of subjects that develop changes in detectable antidrug antibodies to MEDI4736(First dose of MEDI4736 through 6 months after the last dose of study medication)
- Disease Control Rate(Screening through 5 years after the last subject receives the first dose of study medication)
- Number of subjects that develop changes in detectable antidrug antibodies to tremelimumab(First dose of tremelimumab through 6 months after the last dose of study medication)