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临床试验/EUCTR2018-003711-21-CZ
EUCTR2018-003711-21-CZ进行中(未招募)1 期

An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Avelumab (MSB0010718C) Clinical Studies - Avelumab Program Rollover Study

Merck KGaA0 个研究点目标入组 312 人开始时间: 2019年2月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Merck KGaA
入组人数
312

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of Merck KGaA
  • - 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
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 103
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 209

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  • - Participant has been withdrawn from avelumab parent study for any reason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

研究者

发起方
Merck KGaA

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