NCT02966548已完成1 期
A Phase 1 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
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年1月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of laboratory abnormalities
研究概览
简要总结
This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable)
- •Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
- •Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
- •Males and Females, ages 20 years or older, inclusive
排除标准
- •Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease
- •Other concomitant malignancies (with some exceptions per protocol)
- •Any active autoimmune disease or history of known or suspected autoimmune disease
- •History of uncontrolled or significant cardiovascular disease
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Monotherapy
Experimental
Relatlimab (BMS-986016) administered every 2 weeks as a single agent intravenous formulation
干预措施: Relatlimab (Drug)
Combination Therapy
Experimental
Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation
干预措施: Relatlimab (Drug)
Combination Therapy
Experimental
Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation
干预措施: Nivolumab (Drug)
结局指标
主要结局
Number of laboratory abnormalities
时间窗: Approximately 2.2 years
Number of serious adverse events (SAE)
时间窗: Approximately 2.2 years
Number of deaths
时间窗: Approximately 2.2 years
Number of adverse events (AE)
时间窗: Approximately 2.2 years
次要结局
- Time of maximum observed serum concentration (Tmax) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Total body clearance (CLT) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Accumulation index; ration of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Maximum observed serum concentration (Cmax) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Frequency of positive anti-drug antibody (ADA) to Nivolumab(Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Trough observed serum concentration (Ctrough) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Concentration at the end of a dosing interval (Ctau) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Effective elimination half-life (T-HALFeff) that explains the degree of AUC accumulation observed (T-HALFeff AUC) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Degree of fluctuation or fluctuation index ([Cmax - Ctau]/Css,avg) (DF) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Volume of distribution at steady state (Vss) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Best overall response (BOR)(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Duration of response (DOR)(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Frequency of positive anti-drug antibody (ADA) to BMS-986016(Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
- Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016(Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up)
研究者
研究点 (1)
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