EUCTR2014-002351-26-SE进行中（未招募）1 期
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab versus Ipilimumab after Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects who are at High Risk for RecurrencePharmacogenetics Blood Sample Amendment 01 (site-specific)- dated 03-dec-2014Protocol Amendment 06 - Sweden specific - dated 06-Mar-2015 - CheckMate 238: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 238)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,070
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
- •-Man and woman, 15 years or older (in some countries, only subjects aged 18 years or older will be recruited)
- •-Completely removed melanoma by surgery performed within 12 weeks of randomization
- •-Stage IIIb/C or Stage IV before complete resection
- •-No previous anti-cancer treatment
- •-Adequate function of the blood, kidney, and liver
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 870
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 190
排除标准
- •-Ocular or uveal melanoma
- •-History of carcinomatosis meningitis
- •-History of auto-immune disease
- •-Previous non-melanoma cancers unless complete remission since 3 years
- •-Treatment directed against the resected melanoma that is administrated after the surgery
- •-Postive testing for hepatitis B, hepatitis C, or known HIV
研究者
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