HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer High Risk Pathologic Features Following Surgical Salvage and Are Not Eligible for Post-operative Radiation Therapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rate of recurrence at 1 year, will be measured by RECIST 1.1 as the primary measure for assessment of tumor, date of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., discontinuation of study treatment).
研究概览
简要总结
The study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.
详细描述
Approximately 30-40% of patients treated with a curative intent for locally advanced squamous cell carcinoma of the head and neck cancer will experience an isolated loco-regional recurrence or a second primary tumor in the previously radiated tissues1-5. Patients with recurrent head and neck cancer frequently recur locally and are still amenable for curative interventions. The current recommendations for treatment of these recurrent and second primary tumors includes surgical resection whenever possible as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy.
Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Many trials underway at the present time explore the use of immunotherapy in earlier stages of head and neck cancer than the ones already studied. However, patients undergoing salvage therapy are understudied and no major cooperative group or industry trial is addressing this group of 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years or older, of either gender, with the ability to consent to participation in the study.
- •Patients must have a history of squamous cell carcinoma of the head and neck involving any sub-site in the head and neck area except nasopharynx, paranasal sinuses, and salivary gland tumors.
- •All patients must have recurred following definitive therapy with any combination of surgery, radiation, and/or chemotherapy.
- •All patients must have undergone salvage surgery in an attempt to excise all recurrent disease.
- •Salvage radiation therapy must not be an option available to the patient.
- •Patients must have high risk features such extra nodal invasion, positive margins, perineural invasion or vascular embolism.
排除标准
- •Patients with macroscopic residual disease
- •Patient is eligible for radiation therapy.
- •Performance status more than
- •Contraindications for immunotherapy, autoimmune disease, allergy to medication, steroid use at baseline.
- •Patients with other previous cancers excluding CIN, DCIS, non-melanoma skin cancers
- •Patients previously treated with immunotherapy <12months prior
- •Patients with synchronous cancers "not included in the inclusion criteria"
研究组 & 干预措施
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
干预措施: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] (Drug)
结局指标
主要结局
Rate of recurrence at 1 year, will be measured by RECIST 1.1 as the primary measure for assessment of tumor, date of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., discontinuation of study treatment).
时间窗: 1 year
Primary objective
次要结局
- Determine the feasibility of immunotherapy for head and neck cancer following salvage surgery to produce preliminary data for 15 patients regarding efficacy. All side effects and symptoms will be assessed by CTCAE v5.0.(1 year)
- Rate of completion of all planned therapy. All drug related toxicities will be graded by CTCAE v5.0.(through study completion, an average of 1 year)
- Toxicity rates measured by laboratory assessments and all adverse events and serious adverse events will be assessed by CTCAE v5.0.(through study completion, an average of 1 year)
研究者
Haythem Ali, M.D.
Principle Investigator
Henry Ford Health System