A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Participants With Cisplatin Ineligible and Cisplatin Eligible Locally Advanced 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
- 74
- 试验地点
- 22
- 主要终点
- Number of Participants With an Adverse Event Leading to Dose Modification
研究概览
简要总结
This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin
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 proven squamous cell carcinoma of the head and neck (SCCHN) from one of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx
- •Locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach
- •No previous radiotherapy or systemic treatment for SCCHN
排除标准
- •Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primary
- •Clinical or radiological evidence of metastatic disease
- •Prior radiotherapy that overlaps with radiation fields
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Arm A
Cohort 1
干预措施: Nivolumab (Biological)
Arm A
Cohort 1
干预措施: Radiotherapy (Radiation)
Arm B
Cohort 1
干预措施: Cetuximab (Drug)
Arm B
Cohort 1
干预措施: Radiotherapy (Radiation)
Arm C
Cohort 2
干预措施: Nivolumab (Biological)
Arm C
Cohort 2
干预措施: Cisplatin (Drug)
Arm C
Cohort 2
干预措施: Radiotherapy (Radiation)
Arm D
Cohort 2
干预措施: Cisplatin (Drug)
Arm D
Cohort 2
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Number of Participants With an Adverse Event Leading to Dose Modification
时间窗: 30 Days
Number of Participants with an Adverse Event Leading to dose modification
Number of Participants With Select Adverse Events
时间窗: 30 Days
Number of Participants with select adverse events. Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.
Number of Participants Who Experienced Death
时间窗: 100 days
Number of Participants who experienced death
Number of Participants With an Abnormality in Specific Liver Tests
时间窗: 30 days
Number of participants with an abnormality in specific liver tests
Number of Participants With an Serious Adverse Event (SAE)
时间窗: 30 days
Number of Participants with an Serious Adverse Event (SAE)
Number of Participants With an Adverse Event Leading to Discontinuation
时间窗: 30 Days
Number of Participants with an Adverse Event Leading to Discontinuation
Number of Participants With an Adverse Event (AE)
时间窗: 30 Days
Number of Participants with an Adverse Event
Number of Participants With an Immune-mediated Adverse Event (IMAE)
时间窗: 100 days
Number of Participants with an immune-mediated adverse event (IMAE)
Time to Onset and Time to Resolution of Immune-related Adverse Events
时间窗: 100 days
Time to onset and time to resolution of immune-related adverse events
Number of Participants With an Abnormality in Specific Thyroid Tests
时间窗: 30 Days
Number of participants with an abnormality in specific thyroid tests
次要结局
未报告次要终点