A Phase 1/2, Open-Label Study of Nivolumab (BMS-936558) in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors (CheckMate 077: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 077)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- The Number of Participants Experiencing Drug-Related Grade 3-4 Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to determine whether nivolumab is safe and effective in the treatment of advanced or recurrent solid tumors in Chinese subjects.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese subjects with advanced or recurrent solid tumors
排除标准
- •Subjects with brain metastases are excluded unless clinically stable for more than 2 weeks at the time of enrollment as determined by the investigator
- •Subjects with carcinomatous meningitis are excluded
研究组 & 干预措施
Nivolumab monotherapy
Nivolumab specified dose on specified days
干预措施: Nivolumab (Drug)
Cohort Expansion
Nivolumab specified dose on specified days
干预措施: Nivolumab (Drug)
结局指标
主要结局
The Number of Participants Experiencing Drug-Related Grade 3-4 Adverse Events (AEs)
时间窗: From first dose to 100 days after last dose (up to approximately 28 months)
A drug related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug that has a causal relationship with the treatment. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe and Grade 4= Life-threatening.
The Number of Participants Experiencing Drug-Related Grade 3-4 Serious Adverse Events (SAEs)
时间窗: From first dose to 100 days after last dose (up to approximately 28 months)
A drug related serious adverse event (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event that has a casual relationship with the treatment. SAEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe and Grade 4= Life-threatening.
The Number of Participants Experiencing Abnormal Hepatic Laboratory Test Results
时间窗: From first dose to 100 days after last dose (up to approximately 28 months)
The number of participants with the following laboratory abnormalities from the following on-treatment evaluations: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
The Number of Participants Experiencing Toxicity Grade 3-4 Laboratory Test Results
时间窗: From first dose to 100 days after last dose (up to approximately 28 months)
The number of participants with Grade 3-4 laboratory results according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Note: Grade 4 Toxicities not included in the below table if there were no participants that experienced Grade 4 in that category. Grade 3: prolonged recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae \[e.g., renal impairment, pulmonary infiltrates\]. Grade 4: Life-threatening; pressor or ventilatory support indicated.
次要结局
- Best Overall Response (BOR)(From first dose up to approximately 28 months)
- Duration of Response (DOR)(From the date of first response (CR or PR) to the date of the first documented tumor progression or death due to any cause, whichever occurs first. (Up to approximately 28 months))
- Objective Response Rate (ORR)(From first dose up to approximately 28 months)
- Response Rate at 24 Weeks(Week 24)
- Disease Control Rate (DCR) at 24 Weeks(Week 24)
- The Number of Participants With Positive Anti Drug Antibody (ADA) Assessments at Baseline and Positive or Negative ADA Samples After Treatment(From pre-dose on day 1 Cycle 1 up to participants end of study (up to approximately 28 months))
- Cmax - Maximum Observed Serum Concentration(Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose))
- Tmax - Time of Maximum Observed Serum Concentration(Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose))
- AUC (0-T)-Area Under the Plasma Concentration-Time Curve(Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose))
- AUC(TAU) - Area Under the Concentration-Time Curve in One Dosing Interval(Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose))
- Ceoinf - Serum Concentration Achieved at the End of Study Drug Infusion(End of infusion on Day 1 of Cycle 1, 3, 5, 6)
- Ctrough - Trough Observed Serum Concentration at the End of Dosing Interval(Day 1 Cycle 3, 5, 6 (168 hours post dose [Cohort A-B], 336 hours post dose [Cohort C-D]))
- Ctau - Concentration at the End of Dosing Interval(Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose))
- T-HALFeff - Effective Elimination Half-Life(Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose))
- CLT - Total Body Clearance(Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose))
- AI - Accumulation Index (Cmax)(Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose))
- AI - Accumulation Index (Ctau)(Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose))
- AI - Accumulation Index (AUC)(Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose))