Neoadjuvant Pembrolizumab Plus Cetuximab in Betel Nut-Associated Locally Advanced Oral Cavity Squamous Cell Carcinoma in the Commonwealth of the Northern Mariana Islands: A Prospective, Open Label, Single Arm, Single Center, Non-randomized, Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1.Overall Response Rate to neoadjuvant immunotherapy in patients with treatment naive Stage IIII-IV betal-nut-associated oral cavity carcinoma
研究概览
简要总结
The goal of this clinical trial is to learn the overall response rate of giving immunothrapy before surgery in treatment-naive, advanced stage patients with Betal-nut-associated oral cavity cancer.
The outcomes to be measured by CT scan are overall response rate of either partial or complete response.
详细描述
Neoajuvant treatment with IV pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph SQ will be given every 6 weeks in 2, 6 week cycles, with IV cetuximab to be given every 2 weeks in 2, 6 week cycles. Disease will be measured by CT scan pre-treatment and at 6 and12 weeks. Following neoadjuvant treatment, patients will attend the University of Southern California 2 to 6 weeks later for SOC chemotherapy and radiation therapy if deemed necessary.
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
- •Documented history of betel-nut chewing
- •confirmed oral cavity squamous cell carcinoma
- •measurable disease via RECIST 1.1
- •Clinical stage III/IV per AJCC 8th edition
- •treatment-naive
排除标准
- •Distant metastatic disease
- •prior treatment for current cancer
- •active immune disease or other condition requiring immunosuppression or chronic corticosteroid use
- •active pneumonitis
- •known hypersensitivity to pembrolizumab or cetuximab
- •pregnant or breast-feeding
- •women of childbearing potential without willingness to use contraception during the trial
研究组 & 干预措施
Neoadjuvant pembrolizumab and cetuximab
neoadjuvant treatment
干预措施: Pembrolizumab and cetuximab (Drug)
结局指标
主要结局
1.Overall Response Rate to neoadjuvant immunotherapy in patients with treatment naive Stage IIII-IV betal-nut-associated oral cavity carcinoma
时间窗: Baseline through 84 weeks
Assess ORR by CT scan using RECIST 1.1 in patients with treatment naive, advanced Stage III-IV Betel-Nut Associated oral cavity squamous cell carcinoma
次要结局
- 1. To evaluate median and 3-year disease-free survival (DFS) following treatment initiation(Baseline to 36 months)
研究者
Peter Brett, MD
Principal Investigator
Commonwealth Healthcare Corporation