A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 76
- 主要终点
- Number of subjects experiencing a dose-limiting toxicity
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 and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.
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
- •Histologic confirmation of advanced solid tumors
- •Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.
排除标准
- •Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
- •Active or prior documented autoimmune disease within the past 2 years
- •Current or prior use of immunosuppressive medication within 14 days with some exceptions.
结局指标
主要结局
Number of subjects experiencing a dose-limiting toxicity
时间窗: First dose of study medication 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 adverse events
时间窗: Screening through 15 months after the last subject enters re-treatment
Number of subjects reporting serious adverse events
时间窗: Screening through 15 months after the last subject enters re-treatment
Change from Baseline in vital signs
时间窗: Screening through 3 months after the last dose of study medication
Change from Baseline in electrocardiogram evaluations
时间窗: Screening through 3 months after the last dose of study medication
Overall Response Rate in Select Tumor Types
时间窗: First dose of study medication through 15 months after the last subject enters re-treatment
次要结局
- Duration of Response(First dose of study medication through 15 months after the last subject enters re-treatment)
- Overall Survival(First dose of study medication through 15 months after the last subject enters re-treatment)
- Tremelimumab area under the concentration-curve(First dose of tremelimumab through 3 months after the last dose of study medication)
- Overall Response Rate(First dose of study medication through 15 months after the last subject enters re-treatment)
- Disease Control Rate(First dose of study medication through 15 months after the last subject enters re-treatment)
- MEDI4736 area under the concentration-curve(First dose of MEDI4736 through 3 months after the last dose of study medication)
- Progression-Free Survival(First dose of study medication through 15 months after the last subject enters re-treatment)
- Individual MEDI4736 concentrations(First dose of MEDI4736 through 3 months after the last 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 detectable antidrug antibodies to MEDI4736(First dose of MEDI4736 through 3 months after the last dose of study medication)
- Number of subjects that develop antidrug antibodies to tremelimumab(First dose of tremelimumab through 3 months after the last dose of study medication)