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临床试验/EUCTR2018-001423-40-ES
EUCTR2018-001423-40-ES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

Bristol-Myers Squibb International Corporation0 个研究点目标入组 1,020 人开始时间: 2018年10月9日最近更新:
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
1,020

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

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
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 51
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 561
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 408

排除标准

  • - Active brain metastases or leptomeningeal metastases
  • - Uveal melanoma
  • - Participants with an active, known or suspected autoimmune disease

研究者

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An Investigational Immunotherapy Study of NKTR-214... | 临床试验