EUCTR2012-005371-13-ES进行中（未招募）不适用
A Phase 3, Randomized, Double- Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Versus Ipilimumab Monotherapy in Subjects with Previously Untreated, Unresectable or Metastatic MelanomaPharmacogenetics Blood Sample Protocol Amendment 01, version 1.0,dated 19-Mar-2013
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,144
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
- •? Histologically confirmed stage III (unresectable) or stage IV melanoma
- •? Treatment naïve patients
- •? Measurable disease by CT or MRI per RECIST 1.1 criteria.
- •? Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses.
- •? ECOG PS 0 or 1
- •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 795
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 349
排除标准
- •? Active brain metastases or leptomeningeal metastases
- •? Ocular melanoma
- •? Subjects with active, known or suspected autoimmune disease
- •? Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
- •? Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody
研究者
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