A Single Arm Phase 2 Study of Adjuvant Nivolumab After Salvage Resection in Head and Neck Squamous Cell Carcinoma Patients Previously Treated With Definitive Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Percentage of patients with Grade 3 and 4 adverse events of nivolumab
研究概览
简要总结
The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.
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
- •Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options
- •Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated.
- •Able to provide archived biopsy or resected tissue.
- •Adequate performance status and labs.
排除标准
- •Patients who did not receive at least radiotherapy as prior definitive treatment.
- •Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control.
- •Has nasopharyngeal or sinonasal carcinoma.
- •Has confirmed metastatic disease.
研究组 & 干预措施
Nivolumab
Nivolumab starting 4-11 weeks after surgery for 6 doses.
干预措施: Nivolumab (Drug)
结局指标
主要结局
Percentage of patients with Grade 3 and 4 adverse events of nivolumab
时间窗: 28 weeks
Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab
时间窗: AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one Grade 3 or Grade 4 adverse while on treatment of nivolumab.
次要结局
- Percentage of patients any grade adverse events of nivolumab(28 weeks)
- Disease free survival(2 year)
- Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab(AE collection occurs during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.)
- Disease Free Survival(Median follow up was 22.1 months)
- Disease Free Survival(2 year)
研究者
Trisha Wise-Draper
Principal Investigator
University of Cincinnati