A Phase 2 Feasibility Study Combining Pembrolizumab and Metformin to Harness the Natural Killer Cytotoxic Response in Metastatic Head and Neck Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Overall Response by RECIST 1.1 and iRECIST
研究概览
简要总结
The purpose of this study is to determine anti-tumor activity by measuring overall response rate in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.
详细描述
Recurrent and/or metastatic HNSCC patients will be treated with combination of metformin and pembrolizumab. Patients will be randomized into arms 1 and 2, to either receive Metformin prior to pembrolizumab or to begin Metformin after pembrolizumab treatment begins. The patients are randomized for the exploratory endpoints in order to better understand the difference of effects of metformin versus pembrolizumab on the immune system although efficacy is based on combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically or cytologically confirmed recurrent or metastatic non-cutaneous HNSCC for which there are no surgical or radiation curative options.
- •Patients may have received up to 3 prior lines of therapy for metastatic or recurrent disease.
- •ECOG performance status ≤2
排除标准
- •Patients with nasopharyngeal HNSCC will be excluded
- •Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study.
- •Patients who have not recovered from adverse events due to prior anti-cancer therapy
- •Patients who have previously received PD-1 or PD-L1 inhibitors for metastatic/recurrent disease
- •Patients currently receiving metformin or who have received metformin in the last 6 months
研究组 & 干预措施
Arm 2: Metformin after Pembrolizumab
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
干预措施: Pembrolizumab (Drug)
Arm 1: Metformin before Pembrolizumab
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
干预措施: Pembrolizumab (Drug)
Arm 2: Metformin after Pembrolizumab
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
干预措施: Metformin Extended Release Oral Tablet (Drug)
Arm 1: Metformin before Pembrolizumab
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
干预措施: Metformin Extended Release Oral Tablet (Drug)
结局指标
主要结局
Overall Response by RECIST 1.1 and iRECIST
时间窗: 2 years
To determine anti-tumor activity by measuring overall response rate by RECIST 1.1 and iRECIST in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.
次要结局
- Number of patients with adverse events measured by CTCAE v5.0(2 years)
- Progression Free Survival (PFS)(1 year)
- Overall Survival (OS)(1 year)
研究者
Trisha Wise-Draper
Principal Investigator
University of Cincinnati