2023-509466-38-00招募中3 期
B9991046 - AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 14
- 试验地点
- 11
- 主要终点
- AEs leading to permanent discontinuation of study intervention
研究概览
简要总结
To monitor the safety and tolerability of study intervention(s)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Any participant who is receiving study treatment and deriving significant clinical benefit (as determined by the Principal Investigator) or is in the safety and/or survival follow-up period in a Pfizer-sponsored Avelumab Parent Study.
- •Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females) of the applicable Avelumab Continuation Sub-Study Protocol.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the appliable Avelumab Continuation Sub- Study Protocol.
- •Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
排除标准
- •Female participants who are pregnant or breastfeeding.
- •Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
结局指标
主要结局
AEs leading to permanent discontinuation of study intervention
AEs leading to permanent discontinuation of study intervention
All SAEs
All SAEs
次要结局
未报告次要终点
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (11)
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