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临床试验/EUCTR2017-002499-14-ES
EUCTR2017-002499-14-ES进行中(未招募)1 期

A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined with Nivolumab versus Nivolumab in Participants with Metastatic or Unresectable Melanoma that is Previously Untreated

Bristol-Myers Squibb International Corporation0 个研究点目标入组 933 人开始时间: 2017年11月16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
933

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 less than or equal to 1
  • - Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)
  • - Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
  • - Measurable disease
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 28
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 634
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 271

排除标准

  • - Active brain metastases or leptomeningeal metastases
  • - Uveal or ocular melanoma
  • - Participants with active, known, or suspected autoimmune disease
  • - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured

研究者

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