NCT05498480已完成1 期
A Phase 1 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) in Chinese Participants With Advanced Solid Tumors
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年7月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants with Immune-mediated Adverse Events (IMAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and drug levels of relatlimab combined with nivolumab in Chinese participants with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologic or cytological confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable) except for participants with primary central nervous system (CNS) tumors.
- •Participants must have received, and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (immune check inhibitor-experienced or non-experienced population may be included), if such a therapy exists. Participants who refuse or are ineligible for standard therapy will be allowed to enroll provided their refusal/ineligibility is documented in medical records.
- •Eastern Cooperative Oncology Group (ECOG) 0 to 1.
排除标准
- •Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T-lymphocyte-associated protein 4 [anti-CTLA-4] or anti-programmed cell death protein 1 [anti-PD-1]/programmed death-ligand 1 [PD-L1] treatment or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).
- •Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •Prior treatment with LAG-3 targeted agents.
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Number of Participants with Immune-mediated Adverse Events (IMAEs)
时间窗: Up to 123 Weeks
Maximum Observed Plasma Concentration (Cmax) of Relatlimab
时间窗: Up to 123 Weeks
Number of Participants with Serious Adverse Events (SAEs)
时间窗: Up to 123 Weeks
Number of Participants with Clinical Laboratory Abnormalities
时间窗: Up to 123 Weeks
Number of Participants with Dose-Limiting Toxicities (DLTs)
时间窗: Up to 123 Weeks
Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
时间窗: Up to 123 Weeks
Trough-observed serum concentration (Ctrough) of Relatlimab
时间窗: Up to 123 Weeks
Number of Deaths
时间窗: Up to 123 Weeks
Number of Participants with AEs Leading to Discontinuation
时间窗: Up to 123 Weeks
Number of Participants with Adverse Events (AEs)
时间窗: Up to 123 Weeks
次要结局
- Ctrough of Nivolumab(Up to 123 Weeks)
- Percentage of Participants Positive for ADAs to Nivolumab(Up to 123 Weeks)
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator(Up to 123 Weeks)
- Disease Control Rate (DCR) per RECIST v1.1 by Investigator(Up to 123 Weeks)
- Duration of Response (DOR) per RECIST v1.1 by Investigator(Up to 123 Weeks)
- Best Overall Response (BOR) per RECIST v1.1 by Investigator(Up to 123 Weeks)
- Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab(Up to 123 Weeks)
- Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab(Up to 123 Weeks)
研究者
研究点 (1)
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