NCT04058756进行中（未招募）1 期
An Open-label, Multi-center Rollover Protocol for Continued Characterization of Safety and Tolerability for Subjects Who Have Participated in a Novartis-sponsored Spartalizumab Study as Single Agent or in Combination With Other Study Treatments
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 51
- 主要终点
- Frequency and nature of AE and SAE by subject
研究概览
简要总结
The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment,
- •Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.
- •Other protocol defined inclusion criteria may apply
排除标准
- •Subject has been permanently discontinued from spartalizumab in the parent protocol for any reason other than enrollment in the Roll over Study
- •Subject does not meet the criteria specified in the parent protocol criteria for continued study treatment.
研究组 & 干预措施
PDR001
Experimental
All subjects in all combination will be entered in one arm
干预措施: PDR001 (Drug)
结局指标
主要结局
Frequency and nature of AE and SAE by subject
时间窗: 5 years
Safety data.
Number of subjects with PDR001 dose interruption and/or reduction
时间窗: 5 years
次要结局
- Number of subjects receiving PDR001(5 years)
- Subject's exposure duration(5 years)
研究者
研究点 (51)
Loading locations...
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