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临床试验/EUCTR2018-002108-15-BE
EUCTR2018-002108-15-BE进行中(未招募)1 期

Phase 1/2 Study of BMS-986310 Administered Alone and in Combination with Nivolumab in Participants with Advanced Solid Tumors

Bristol-Myers Squibb International Corporation0 个研究点目标入组 280 人开始时间: 2018年8月1日最近更新:
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相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
280

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

  • - Patients with measurable disease per RECIST v1.1 and have at least one lesion accessible for biopsy.
  • - ECOG performance status less than or equal to 1
  • Part 1 and Sub-study B:
  • i) Part 1 participants must have advanced or metastatic disease where no other standard of care treatment option is possible.
  • ii) Sub-study B participants must have advanced or metastatic disease where no other standard of care treatment is possible, and they must have had disease progression on an anti-PD-(L)1 based regimen as their most recent prior therapy;
  • Tumor size equal to or greater than 1 cm
  • Sub-study A:
  • i) Males and females with histologically confirmed TNBC with no prior treatment for TNBC
  • i) Patients with NSCLC
  • ii) Patients with Pancreatic Cancer
  • iii) Patients with TNBC
  • iiii) Patients with CRC
  • 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 168
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 112

排除标准

  • - History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs (NSAIDs), or those with adverse reactions to an NSAID that is currently prescribed
  • - Participants with an active, known or suspected autoimmune disease.

研究者

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