EUCTR2018-000340-26-DE进行中（未招募）1 期
A Phase 1/2 Study of BMS-986253 in Combination with Nivolumab or Nivolumab plus Ipilimumab in Advanced Cancers
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
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
- •- At least 1 lesion accessible for biopsy
- •- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •- Non-small cell lung carcinoma (only Part 1A and Part 1 Cohorts 1B1 through 1B5 [enrolled through revised Protocol 03]. Participants with NSCLC will not be allowed in Parts 1B6, 1B7 and 1C as per protocol Amendment 04).
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •- Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
- •- Participants with active, known or suspected autoimmune disease
- •- Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- •- Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
- •- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
研究者
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