NL-OMON56215招募中3 期
A Phase 3 Randomized Clinical Trial of Nivolumab alone, Nivolumab in Combination with Ipilimumab, or an Investigator's Choice Chemotherapy in Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer - CheckMate 8HW
Bristol-Myers Squibb0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histologically confirmed recurrent or metastatic colorectal cancer
- •(CRC) irrespective of prior treatment history with chemotherapy and/or
- •targeted agents not
- •amenable to surgery (Applicable only during Part 1 enrollment of the
- •-Histologically confirmed recurrent or metastatic CRC with no prior
- •treatment history with chemotherapy and/or targeted agents for
- •metastatic disease and not
- •amenable to surgery (Applicable during Part 2 enrollment of the study)
- •- Known tumor MSI-H or dMMR status per local standard of practice
- •- Eastern cooperative oncology group (ECOG) performance status lower
- •than or equal to 1
- •- Other protocol-defined inclusion/exclusion criteria apply
排除标准
- •- Participants with an active, known or suspected autoimmune disease
- •- History of interstitial lung disease or pneumonitis
- •- Known history of positive test for human immunodeficiency virus (HIV)
- •or known acquired immunodeficiency syndrome (AIDS)
- •- Other protocol-defined inclusion/exclusion criteria apply
研究者
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