A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,163
- 试验地点
- 38
- 主要终点
- Objective Response Rate ( ORR )
研究概览
简要总结
To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.
详细描述
All tumor types are now closed for enrollment:
Triple Negative Breast Cancer
Gastric Cancer
Pancreatic Cancer
Small Cell Lung Cancer
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
- •Subjects with histologically or cytologically confirmed locally advanced or metastatic disease of the following tumor types:
- •Triple Negative Breast Cancer
- •Gastric Cancer
- •Pancreatic Cancer
- •Small Cell Lung Cancer
- •Bladder Cancer
- •Ovarian Cancer
- •Subjects must have measurable disease
- •Eastern Cooperative Oncology Group (ECOG) of 0 or 1
- •Adequate hematological and organ function as confirmed by laboratory values
排除标准
- •Active brain metastases or leptomeningeal metastases
- •Subjects with active, known or suspected autoimmune disease
- •Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
- •Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting T cell is also prohibited
研究组 & 干预措施
Arm N - Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Nivolumab (Biological)
Arm N-I, Level 1: Nivolumab+Ipilimumab
Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 1 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Nivolumab (Biological)
Arm N-I, Level 1: Nivolumab+Ipilimumab
Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 1 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Ipilimumab (Biological)
Arm N-I, Level 2: Nivolumab+Ipilimumab
Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Nivolumab (Biological)
Arm N-I, Level 2: Nivolumab+Ipilimumab
Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Ipilimumab (Biological)
Arm N-I, Level 2b: Nivolumab+Ipilimumab
Nivolumab 3 mg/kg solution intravenously plus Ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Nivolumab (Biological)
Arm N-I, Level 2b: Nivolumab+Ipilimumab
Nivolumab 3 mg/kg solution intravenously plus Ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Ipilimumab (Biological)
Arm N-I, Level 2c: Nivolumab+Ipilimumab
Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Nivolumab (Biological)
Arm N-I, Level 2c: Nivolumab+Ipilimumab
Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Ipilimumab (Biological)
Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib
Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Nivolumab (Biological)
Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib
Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Ipilimumab (Biological)
Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib
Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Cobimetinib (Drug)
结局指标
主要结局
Objective Response Rate ( ORR )
时间窗: 60 months
The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
次要结局
未报告次要终点