EUCTR2014-002241-22-ES进行中（未招募）1 期
A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination with Nivolumab in Advanced /Metastatic Solid Tumors and B Cell Non-Hodgkins Lymphoma.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
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
入选标准
- •For Dose Escalation: Subjects with any previously treated advanced (metastatic or refractory) solid tumor type and B-cell non-Hodgkin lymphoma except subjects who have primary central nervous system tumors or with central nervous system metastases as the only site of active disease )
- •For Cohort Expansion: Subjects must have a previously treated advanced solid tumor or B cell non-Hodgkin?s lymphoma to be eligible:
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •For certain subjects, 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 221
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
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 hepatitis (B or C)
- •History of active or latent tuberculosis.
研究者
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