EUCTR2015-002505-11-ES进行中（未招募）1 期
A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination with Nivolumab (BMS-936558, anti-PD-1 Monoclonal Antibody) in Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •For Dose Escalation:
- •- Subjects with any previously treated advanced (metastatic or refractory) solid tumor
- •For Cohort Expansion:
- •- Subjects must have a previously treated advanced solid tumor to be eligible
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •- Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
- •- Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
- •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 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- Known central nervous system metastases or central nervous system as the only source of disease
- •- Other concomitant malignancies (with some exceptions per protocol)
- •- Active, known or suspected autoimmune disease
- •- Uncontrolled or significant cardiovascular disease
- •- History of chronic hepatitis
- •- History of active hepatitis (B or C)
- •- Impaired liver or bone marrow function
- •- Major surgery less than 1 month before start of the study
研究者
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