An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 361
- 试验地点
- 47
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.
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
- •Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- •Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
- •Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting
- •Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria
排除标准
- •Active brain metastases or leptomeningeal metastases are not allowed
- •Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg: mucosal melanoma) are not allowed
- •Subjects with active, known or suspected autoimmune disease
研究组 & 干预措施
Arm A: Nivolumab
Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression
干预措施: Nivolumab (Drug)
Arm B: Cetuximab/Methotrexate/Docetaxel
Cetuximab intravenous (IV) Solution for Injection 400 mg/m2 (first dose) then 250 mg/m2 weekly until disease progression
OR
Methotrexate intravenous (IV) Solution for Injection 40 or 60 mg/m2 weekly until disease progression
OR
Docetaxel intravenous (IV) Solution for Injection 30 or 40 mg/m2 weekly until disease progression
干预措施: Cetuximab (Drug)
Arm B: Cetuximab/Methotrexate/Docetaxel
Cetuximab intravenous (IV) Solution for Injection 400 mg/m2 (first dose) then 250 mg/m2 weekly until disease progression
OR
Methotrexate intravenous (IV) Solution for Injection 40 or 60 mg/m2 weekly until disease progression
OR
Docetaxel intravenous (IV) Solution for Injection 30 or 40 mg/m2 weekly until disease progression
干预措施: Methotrexate (Drug)
Arm B: Cetuximab/Methotrexate/Docetaxel
Cetuximab intravenous (IV) Solution for Injection 400 mg/m2 (first dose) then 250 mg/m2 weekly until disease progression
OR
Methotrexate intravenous (IV) Solution for Injection 40 or 60 mg/m2 weekly until disease progression
OR
Docetaxel intravenous (IV) Solution for Injection 30 or 40 mg/m2 weekly until disease progression
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From date of randomization to date of death (Up to approximately 18 months)
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.
次要结局
- Investigator-Assessed Progression-Free Survival (PFS)(From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months))
- Investigator-Assessed Objective Response Rate (ORR)(From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months))