EUCTR2018-001423-40-FI进行中（未招募）1 期
A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma - 17-214-08
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,020
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
- •- Eastern Cooperative Oncology Group (ECOG) performance status of /= 80% (minors ages 12-17 only)
- •- Histologically confirmed stage III (unresectable) or stage IV melenoma
- •- Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant treatment and/or neoadjuvant treatment for melanoma with approved agents
- •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 555
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 404
排除标准
- •- Active brain metastases or leptomeningeal metastases
- •- Uveal melanoma
- •- Participants with an active, known or suspected autoimmune disease
- •Other protocol defined inclusion/exclusion criteria could apply.
研究者
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