EUCTR2014-002605-38-IT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 - CA224-020
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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
- •immunooncology 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-
- •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 or 1
- •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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 580
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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