Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
- 试验地点
- 12
- 主要终点
- Disease Free Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
研究概览
简要总结
The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.
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
- •Patients eligible for resection with one or more of the following
- •Any T stage with ≥ N2 disease;
- •T4 disease, any N stage;
- •T3 Oral Cavity, any N stage; or
- •Clinical evidence of extra-capsular extension on scans.
- •Must be willing to undergo definitive resection with neck dissection.
- •Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
- •Adequate labs
- •Appropriate staging imaging.
排除标准
- •Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment.
- •Nasopharyngeal or sinonasal carcinoma
- •Confirmed metastatic disease
- •Human Papillomavirus (HPV)+ disease of the oropharynx
- •Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C
研究组 & 干预措施
Pembrolizumab
Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin
干预措施: Pembrolizumab (Drug)
Pembrolizumab
Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin
干预措施: Cisplatin (Drug)
Pembrolizumab
Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin
干预措施: Surgery (Procedure)
Pembrolizumab
Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Disease Free Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
时间窗: 1 year
• High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins.
Disease Free Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation
时间窗: 1 year
• Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins.
Number of Participants With Treatment Related Adverse Effects
时间窗: All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution.
Number of participants with treatment related adverse effects as assessed using CTCAE v4.0 of pembrolizumab when combined with radiation alone and chemoradiation. Compared as percentage of grade 3 and 4 adverse events with historical control percentages.
次要结局
- Tumor Immune Response to Pembrolizumab as Defined by PD-L1 CPS in the Baseline Tumor Tissue(1 week between receiving a pre-surgery dose of pembrolizumab and surgery when the biopsy was taken)
- Overall Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation(1 year)
- Overall Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation(1 year)
研究者
Trisha Wise-Draper
Principal Investigator
University of Cincinnati