A Safety Study of Nivolumab in Patients With Recurrent and/or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 351
- 试验地点
- 18
- 主要终点
- Incidence for high-grade (CTCAE v4.0 Grade 3-4-5) adverse events of interest (AEI). AEI are adverse reactions known to be related to nivolumab (i.e. skin, endocrinopathy, gastrointestinal, hepatic, renal, pulmonary, and hypersensitivity adverse events)
研究概览
简要总结
Recurrent and/or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) are a common clinical situation and although this group of patients has very heterogeneous disease characteristics, they share a dismal prognosis with a median survival time around 6-11 months and a relatively poor quality of life.
Immunotherapy approaches have recently demonstrated clinical efficacy in more than twenty cancer types, including melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC) and SCCHN. Nivolumab demonstrated significant overall survival benefit as treatment for recurrent SCCHN in a randomized phase III Study CA209141 conducted on a cohort of 361 patients (240 in the nivolumab arm and 121 in the standard therapy arm), presenting this condition and whose disease had progressed within 6 months after platinum-based chemotherapy. In this study, treatment with nivolumab resulted in significantly longer survival than treatment with standard therapy with a median overall survival of 7.5 months vs 5.1 months (p=0.01).
The main objective of the study is to provide additional insight into the frequency of high-grade AEs related to nivolumab and their outcome, and thus supplement the growing safety database of nivolumab-treated recurrent and/or metastatic squamous cell carcinoma of the head and neck patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nivolumab
All patients enrolled in the study will received Nivolumab injections, 3mg/kg IV, every 2 weeks, up to 12 cycles (1 cycle = 28 days).
干预措施: Nivolumab Injection (Drug)
结局指标
主要结局
Incidence for high-grade (CTCAE v4.0 Grade 3-4-5) adverse events of interest (AEI). AEI are adverse reactions known to be related to nivolumab (i.e. skin, endocrinopathy, gastrointestinal, hepatic, renal, pulmonary, and hypersensitivity adverse events)
时间窗: Last dose + 100 days
The rate (and its 95%CI) of patients who report at least one high-grade (Grade 3-4 and Grade 5) adverse events of interest will be provided.
次要结局
- Time to onset of grade 3+ AEI(last dose + 100 days)
- Duration of all immune modulating medications given for the select event and summary of patients with resolution of AEs after initiating these therapies.(Last dose + 100 days)
- Rate of patients with at least one or more doses of nivolumab delayed (or cancelled) due to AE(Up to 24 months of treatment)
- Time to resolution of grade 3-4 AEI to grade 1(the time from the date of grade 3-4 until the date of grade 1, assessed up to 36 months.)
- Rate of patients with nivolumab definitely withdrawn due to AE(Up to 24 months of treatment)
- Rate of AEI of maximum grade 1-2(Last dose + 100 days)
- Overall survival (OS)(Up to 36 months.)
- Rate of Nivolumab-related deaths(Up to 36 months.)
- Rate of patients who received immune modulating medication or hormonal replacement therapy(Last dose + 100 days)
- Progression free survival (PFS)(Up to 36 months.)
- Objective response rate (ORR) (complete response and partial response according to RECIST 1.1 and to iRECIST) during nivolumab treatment(The time between the fist dose of treatment until the best response, assessed up to 36 months.)
- Pseudo progression(The time between the first dose of treatment until the first confirmed progression, assessed up to 36 months.)