EUCTR2014-002605-38-AT进行中（未招募）1 期
A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
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 cervical, ovarian, bladder and CRC, head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.
- •For Dose Expansion: all of the above in escalation except for cervical, ovarian and CRC
- •Progressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts.
- •ECOG performance status of 0 to 2
- •At least 1 lesion with measurable disease at baseline
- •Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 840
排除标准
- •- Primary CNS tumors or solid tumors with CNS metastases as the only site of active disease
- •- Autoimmune disease
- •- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
- •- Uncontrolled CNS metastases
研究者
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