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临床试验/EUCTR2013-002844-10-DE
EUCTR2013-002844-10-DE进行中（未招募）1 期

A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid Tumors+ Pharmacogenetics Blood Sample Amendment 01 (site-specific), version 1.0, dated 16-jul-2013+ Protocol Amendment Number 02, country-specific, version 1.0, dated 18-sep-2013+ Protocol Amendment 04- German-Specific; dated 13-nov-2013, version 1.0+ Protocol Amendment 07 (site-specific), version 1.0, dated 04-jun-2014+ Protocol Amendment 14, site-specific, dated 26-Oct-2016 - CheckMate 032:CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 032

Bristol-Myers Squibb International Corporation0 个研究点目标入组 1,620 人开始时间: 2013年10月7日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
1,620
研究概览入排标准研究者记录与标识符相似试验

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

  • •- Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:
  • •- Triple Negative Breast Cancer
  • •- Gastric Cancer
  • •- Pancreatic Cancer
  • •- Small Cell Lung Cancer
  • •- Ovarian Carcinoma
  • •- Bladder Cancer
  • •- Subjects must have measurable disease
  • •- ECOG of 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 810
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 810

排除标准

  • •Active brain metastases or leptomeningeal metastases.
  • •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 therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, including ipilimumab; or other medicines specifically targeting T cell is also prohibited.

研究者

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