A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 413
- 试验地点
- 38
- 主要终点
- Number of participants with Adverse Events (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
研究概览
简要总结
The purpose of this study is to test the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
- •Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.
排除标准
- •History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
- •Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part 2B2
干预措施: Nivolumab/relatlimab/rHuPH20 (Drug)
Part 2B3
干预措施: Bevacizumab (Drug)
Part 1B1
干预措施: Nivolumab and rHuPH20 (Drug)
Part 1B2
干预措施: Nivolumab/relatlimab/rHuPH20 (Drug)
Part 2B1
干预措施: Nivolumab and rHuPH20 (Drug)
Part 1A
干预措施: BMS-986482 (Drug)
Part 1B2
干预措施: BMS-986482 (Drug)
Part 1B3
干预措施: BMS-986482 (Drug)
Part 1C
干预措施: BMS-986482 (Drug)
Part 2A
干预措施: BMS-986482 (Drug)
Part 2B3
干预措施: BMS-986482 (Drug)
Part 1B1
干预措施: BMS-986482 (Drug)
Part 1B3
干预措施: Bevacizumab (Drug)
Part 2B2
干预措施: BMS-986482 (Drug)
Part 2B1
干预措施: BMS-986482 (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
时间窗: Up to 135 days post last treatment visit
Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0
时间窗: Up to 135 days post last treatment visit
Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria as assessed by NCI-CTCAE v5.0
时间窗: Up to Day 28
Number of participants with AEs leading to discontinuation as assessed by NCI-CTCAE v5.0
时间窗: Up to 135 days post last treatment visit
Number of participants with Adverse Events (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
时间窗: Up to 135 days post last treatment visit
Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0
时间窗: Up to 135 days post last treatment visit
Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria as assessed by NCI-CTCAE v5.0
时间窗: Up to Day 28
Number of participants with AEs leading to discontinuation as assessed by NCI-CTCAE v5.0
时间窗: Up to 135 days post last treatment visit
Number of deaths as assessed by NCI-CTCAE v5.0
时间窗: Through study completion (Up to 4 years)
次要结局
- Concentration at the end of infusion (Cmax)(Up to 135 days post last treatment visit)
- Time of maximum observed concentration (Tmax)(Up to 135 days post last treatment visit)
- Area under the concentration-time curve in one dosing interval (AUC(TAU))(Up to 135 days post last treatment visit)
- Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by Investigator(Up to 135 days post last treatment visit)