EUCTR2018-004362-34-PT进行中（未招募）1 期
Pan Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab - Pan tumor Nivolumab Rollover Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,231
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
- •-Signed Written Informed Consent
- •-Participants who have completed treatment with nivolumab, progressed on prior nivolumab treatment or discontinued nivolumab due to toxicity, in the Parent Study are not eligible to receive nivolumab in this study. These participants may be enrolled for safety and survival follow-up only.
- •-Participant is eligible for nivolumab treatment as per the Parent Study and/or Investigator assessed clinical benefit
- •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 654
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 577
排除标准
- •For Participants planning to enter the study on nivolumab treatment:
- •-Participant is not eligible for nivolumab treatment as per the Parent Study
- •-Participants not receiving clinical benefit as assessed by the Investigator (participant is still eligible for study if entering survival follow-up only)
- •-Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant
- •-History of allergy or hypersensitivity to study drug components
- •-Prisoners or participants who are involuntarily incarcerated (Note: Under certain specific circumstances and only in countries where local regulations permit, a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and Bristol-Myers Squibb approval is required.)
- •-Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
- •-Dementia or serious psychiatric condition that may compromise the informed consent process and increase the risks associated with study participation
- •-Participants with any condition which, in the judgment of the Investigator, may pose a significant risk to the subject
- •Participants in survival follow-up have no exclusion criteria.
研究者
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