An Open-Label, Phase 2 Efficacy Study With Window of Opportunity Immune Assessment of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
概览
- 阶段
- 2 期
- 干预措施
- Pembrolizumab
- 疾病 / 适应症
- Squamous Cell Carcinoma of the Head and Neck
- 发起方
- Assuntina G. Sacco, MD
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Disease-Free Survival
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
The purpose of this study is to determine whether pembrolizumab, when given after salvage surgery, is effective in increasing the time a person with squamous cell cancer of the head and neck remains disease-free following locoregional disease recurrence.
详细描述
The purpose of this study is to determine whether pembrolizumab, when given after salvage surgery, is effective in increasing the time a person with squamous cell cancer of the head and neck remains disease-free following locoregional disease recurrence. This is a prospective, multi-center, open label, phase II study with a window of opportunity component in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN) treated with adjuvant pembrolizumab following salvage surgery. Forty-five (45) patients will participate in this study to determine disease-free survival probability at 12 months. Secondary objectives include assessments of disease-free survival probability at 2 years, overall survival, adverse events and toxicity, and immune and molecular correlatives. For the window of opportunity component, patients will be randomized 3:1 in favor of receiving pembrolizumab 200 mg administered intravenously (IV) every three weeks for a maximum of two doses, versus placebo prior to salvage surgery. Approximately three to six weeks following the first dose of pembrolizumab, patients will undergo salvage surgery. Tumor tissue and blood will be collected at the time of surgery for immune correlative studies.
研究者
Assuntina G. Sacco, MD
Associate Professor of Medicine
University of California, San Diego
入排标准
入选标准
- •Has pathologically confirmed SCCHN (oral cavity, oropharynx, larynx, hypopharynx) with evidence of local and/or locoregional recurrence. Laryngeal tumors will only be included if there is evidence of extralaryngeal spread, or there is associated nodal disease. For all other sites, superficial tumors can only be included if there is associated nodal disease.
- •Has a documented disease-free interval (minimum 16 weeks) after initial curative intent therapy.
- •Candidate for salvage resection.
- •Able to provide tissue from diagnostic core biopsy of tumor lesion(s).
- •Patient has adequate organ function.
- •Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication.
- •Female patient of childbearing potential agrees to use adequate birth control.
- •Male patient with a partner of childbearing potential agrees to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
排除标准
- •Patient has disease of nasopharyngeal carcinoma histology.
- •Patient has evidence of metastatic disease.
- •Patient is currently receiving or has received another investigational agent within 4 weeks prior to study Day
- •Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab.
- •Patient has a known history of active TB (Bacillus Tuberculosis).
- •Patient has received a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or baseline) from adverse events due to a previously administered agents.
- •Patient has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day
- •Patients who have had major surgery or have insufficient recovery from surgical-related trauma or wound healing within 14 days from study Day
- •Patient has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- •Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
研究组 & 干预措施
Pembrolizumab
Pembrolizumab 200 mg will be administered by IV infusion every 3 weeks up to 12 months or until disease progression
干预措施: Pembrolizumab
结局指标
主要结局
Disease-Free Survival
时间窗: 12 months
Disease-Free Survival
次要结局
- Disease-Free Survival at 2 years(2 years)
- Overall Survival(3 years)
- Safety: Incidence of Adverse Events, Serious Adverse Events, and Treatment Delays(3 years)