JPRN-jRCT2080223834已完成1 期
A Phase I/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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
入排标准
- 年龄范围
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (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 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)
排除标准
- •Primary central nervous system (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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