NCT03815643进行中（未招募）3 期
An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 205
- 试验地点
- 206
- 主要终点
- Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events
研究概览
简要总结
The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.
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
- •Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of EMD Serono Research & Development Institute, Inc. / Merck KGaA, Darmstadt, Germany
- •Merck Serono Co., Ltd (Japan)
- •Participants currently enrolled in an avelumab parent study and are on active treatment with avelumab or in long-term survival follow-up after treatment
- •Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists
- •Other protocol defined inclusion criteria could apply.
排除标准
- •Participants who are pregnant or breastfeeding
- •Participants still on active treatment: Known hypersensitivity to any of the study intervention ingredients
- •Participant has been enrolled in the comparator arm of avelumab parent study
- •Participant has been withdrawn from avelumab parent study for any reason
- •Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study
- •Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
Avelumab
Experimental
干预措施: Avelumab (Drug)
结局指标
主要结局
Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events
时间窗: From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab)
次要结局
- Overall Survival (OS)(From baseline up to 5 years)
- Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)(From baseline up to 5 years)
- Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR)(From baseline up to 5 years)
研究者
研究点 (206)
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