NCT03994601已完成1 期
A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Bristol-Myers Squibb40 个研究点 分布在 7 个国家目标入组 219 人开始时间: 2019年9月6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
- 219
- 试验地点
- 40
- 主要终点
- Incidence of AEs leading to death
研究概览
简要总结
The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies
排除标准
- •Active, known or suspected autoimmune disease
- •Active malignancy requiring concurrent intervention
- •Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm B: BMS-986288 in combination with Nivolumab
Experimental
干预措施: Nivolumab (Drug)
Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib
Experimental
干预措施: BMS-986288 (Drug)
Arm A: BMS-986288 Monotherapy
Experimental
干预措施: BMS-986288 (Drug)
Arm B: BMS-986288 in combination with Nivolumab
Experimental
干预措施: BMS-986288 (Drug)
Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib
Experimental
干预措施: Nivolumab (Drug)
Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib
Experimental
干预措施: Regorafenib (Drug)
结局指标
主要结局
Incidence of AEs leading to death
时间窗: Up to 2 years
Incidence of Adverse Events (AEs)
时间窗: Up to 2 years
Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria
时间窗: Up to 2 years
Incidence of AEs leading to discontinuation
时间窗: Up to 2 years
Incidence of Serious Adverse Events (SAEs)
时间窗: Up to 2 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review
时间窗: Up to 2 years
Part 2C
次要结局
- Maximum Observed Concentration (Cmax) of BMS-986288(Up to 2 years)
- Time of Maximum Observed Concentration (Tmax) of BMS-986288(Up to 2 years)
- Accumulation Index (AI) of BMS-986288(Up to 4 months)
- Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment(Up to 4 years)
- DOR by RECIST v1.1 by blinded independent central review(Up to 4 years)
- PFS by RECIST v1.1 by blinded independent central review(Up to 4 years)
- Overall Survival (OS) by RECIST v1.1 by blinded independent central review(Up to 4 years)
- Incidence of Adverse Events (AEs)(Up to 100 days following last dose of study treatment)
- Incidence of Serious Adverse Events (SAEs)(Up to 100 days following last dose of study treatment)
- Incidence of AEs leading to death(Up to 100 days following last dose of study treatment)
- Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288(Up to 2 years)
- Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288(Up to 2 years)
- Total Body Clearance (CLT) of BMS-986288(Up to 4 months)
- Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288(Up to 4 months)
- Time to Response (TTR) by RECIST v1.1 by Investigator Assessment(Up to 4 years)
- Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria(Up to 100 days following last dose of study treatment)
- Terminal Half-Life (T-HALF) of BMS-986288(Up to 4 months)
- Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment(Up to 4 years)
- Incidence of AEs leading to discontinuation(Up to 100 days following last dose of study treatment)
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment(Up to 4 years)
- Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288(Up to 2 years)
- Trough Observed Concentrations (Ctrough) of BMS-986288(Up to 2 years)
研究者
研究点 (40)
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