EUCTR2018-000416-21-RO进行中（未招募）1 期
A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 435
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
- •-Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy;
- •-Eastern Cooperative Oncology Group Performance Status of 0 or 1;
- •-Some participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies;
- •-Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some patients;
- •-Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation;
- •-Willing and able to comply with all study procedures.
- •Other protocol defined inclusion criteria could apply.
- •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 327
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 108
排除标准
- •-Participants with primary CNS malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded;
- •-Active, known, or suspected autoimmune disease;
- •-Participants with other active malignancy requiring concurrent intervention;
- •-Prior organ allograft.
- •Other protocol defined exclusion criteria could apply.
研究者
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