2024-514274-46-00招募中3 期
An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Avelumab (MSB0010718C) Clinical Studies
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 13
- 主要终点
- Occurrence of treatment-related non-serious treatment-emergent adverse events (TEAEs), all serious adverse events (SAEs), immune-related adverse events (irAEs), and infusion-related reactions according to the version of National Cancer Institute Common Technology Criteria for Adverse Events (NCI-CTCAE) used in the respective parent study.
研究概览
简要总结
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
- Not Applicable
- 主要目的
- Experimental: Avelumab
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants are ≥ 18 years of age at the time of signing the informed consent.
- •Participants are under enrollment in an avelumab clinical study under the sponsorship of EMD Serono Research & Development Institute, Inc. / Merck KGaA / Merck Serono Co., Ltd (Japan).
- •Participants currently enrolled in an avelumab parent study where the primary/main analysis has been completed and who are: • Currently on active avelumab treatment in any parent study, regardless of indication, OR • In long-term survival follow-up after treatment (participants in Non-Small Cell Lung Cancer [NSCLC], Renal Cell Carcinoma [RCC], Urothelial Carcinoma [UC], and ovarian cancer indications only), OR • Who experienced CR in the parent study and discontinued avelumab treatment according to the parent study protocol.
- •Participants are male or female. Participants on active treatment must agree to continue to use highly effective contraception (ie, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists (Note: The effects of the study intervention on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception, defined in Appendix 3 (Contraception) or as stipulated in national or local guidelines. Highly effective contraception must be used 28 days prior to the first study intervention administration, for the duration of study intervention, and at least for 60 days after stopping study intervention. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the treating physician should be informed immediately).
- •Participants can give signed informed consent, as indicated in Appendix 2 (Study Governance), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
排除标准
- •Participants are pregnant or breastfeeding.
- •For 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 (Note: Participants in the Follow-up Period are eligible).
- •Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study.
结局指标
主要结局
Occurrence of treatment-related non-serious treatment-emergent adverse events (TEAEs), all serious adverse events (SAEs), immune-related adverse events (irAEs), and infusion-related reactions according to the version of National Cancer Institute Common Technology Criteria for Adverse Events (NCI-CTCAE) used in the respective parent study.
Occurrence of treatment-related non-serious treatment-emergent adverse events (TEAEs), all serious adverse events (SAEs), immune-related adverse events (irAEs), and infusion-related reactions according to the version of National Cancer Institute Common Technology Criteria for Adverse Events (NCI-CTCAE) used in the respective parent study.
次要结局
- Overall Survival, from baseline in parent study to date of death due to any cause.
- Progression Free Survival according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by Investigator, from baseline in parent study until progressive disease (PD) or death due to any cause.
- Duration Response assessed from complete response (CR) or partial response (PR) until PD or death due to any cause.
研究者
Global Regulatory Affairs
Scientific
Merck Healthcare KGaA
研究点 (13)
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