NCT03048136撤回3 期
A Phase Ib/II Safety Trial of Nivolumab in Combination With Ipilimumab Administered in Participants With Chemotherapy-naive Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) (CheckMate 955: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 955)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2018年3月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events
研究概览
简要总结
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
详细描述
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
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
- •Stage IV or recurrent non-Small cell lung cancer
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- •Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization
排除标准
- •Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
- •Active, known or suspected autoimmune disease or HIV infection
- •Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
- •Untreated Central Nervous System metastases
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Weight-Based Dose
Experimental
Nivolumab weight-based dose + Ipilimumab
干预措施: Ipilimumab (Drug)
Flat-Dose
Experimental
Nivolumab flat dose + Ipilimumab
干预措施: Nivolumab (Drug)
Flat-Dose
Experimental
Nivolumab flat dose + Ipilimumab
干预措施: Ipilimumab (Drug)
Weight-Based Dose
Experimental
Nivolumab weight-based dose + Ipilimumab
干预措施: Nivolumab (Drug)
结局指标
主要结局
Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events
时间窗: Approximately 3 months
Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events
时间窗: Approximately 3 months
次要结局
- Overall survival (OS) as defined as the time from first dosing to the date of death(Up to 5 years)
- Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)(Up to 24 months)
- Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)(Up to 24 months)
- Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)(Up to 24 months)
研究者
研究点 (1)
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