EUCTR2016-003729-41-ES进行中（未招募）1 期
A Phase 3, Randomized Study of Adjuvant Immunotherapy with Nivolumab Combined with Ipilimumab Versus Ipilimumab or Nivolumab Monotherapy after Complete Resection of Stage IIIb/c/d or Stage IV Melanoma. - CheckMate 915
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
- 1,125
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
- •_Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study;
- •_Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work;
- •_No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 827
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 293
排除标准
- •_History of uveal melanoma;
- •_Weight less then or equal to 40 kg;
- •_Patients with active, known or suspected autoimmune disease;
- •_Prior treatment with interferon (if complete < 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
研究者
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