EUCTR2012-005371-13-AT进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,144
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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不适用
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Phase 3 Study of Nivolumab or Nivolumab plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanomanresectable or metastatic melanomaMedDRA version: 16.0Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864MedDRA version: 16.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864EUCTR2012-005371-13-ESBristol-Myers Squibb International Corporation1,144