An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic 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
- 947
- 试验地点
- 132
- 主要终点
- Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20
研究概览
简要总结
The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck 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
- •Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to curative therapy.
- •No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
- •Measurable disease detected by imaging exam (CT or MRI).
- •Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status.
排除标准
- •Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).
- •No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
- •Participants with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
- •Inadequate hematologic, renal or hepatic function.
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Nivolumab and Ipilimumab
Specified dose on specified days
干预措施: Nivolumab (Biological)
Nivolumab and Ipilimumab
Specified dose on specified days
干预措施: Ipilimumab (Biological)
Extreme Regimen
Specified dose on specified days
干预措施: Cetuximab/Erbitux (Drug)
Extreme Regimen
Specified dose on specified days
干预措施: Cisplatin/Platinol (Drug)
Extreme Regimen
Specified dose on specified days
干预措施: Carboplatin/Paraplatin (Drug)
Extreme Regimen
Specified dose on specified days
干预措施: Fluorouracil/Adrucil (Drug)
结局指标
主要结局
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20
时间窗: From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Overall Survival (OS) in All Randomized Participants
时间窗: From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
次要结局
- Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1(From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months))
- Progression Free Survival (PFS)(From randomization to disease progression or death (Up to approximately 65 months))
- Duration of Objective Response (DOR)(From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months))
- Objective Response Rate (ORR)(From randomization up to approximately 65 months)