A Phase I Study of Avelumab, Palbociclib, and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Kathryn Gold
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- maximum tolerated dose
研究概览
简要总结
The purpose of the study is to find out if the study drugs Avelumab, Cetuximab, and Palbociclib will slow or stop your cancer from getting worse, and whether it causes side effects. The second purpose is to measure whether your cancer responds to the study drugs Avelumab, Cetuximab, and Palbociclib. The study drugs Avelumab, Cetuximab, and Palbociclib are types of drugs called a monoclonal antibody. Monoclonal antibodies are made to recognize, target, and bind to specific proteins on cells the building blocks making up your tissues.
详细描述
This is an open-label phase I trial with a 3+3 dose escalation design. All patients will receive avelumab, cetuximab, and palbociclib. This study will enroll patients with head and neck squamous cell carcinoma not amenable to curative intent therapy.
Treatment will be administered in 28 day cycles with a pre-defined dose escalation schedule.
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
- •Histologically or cytologically proven squamous cell carcinoma of the head and neck not amenable to curative intent therapy.
- •Presence of measurable tumor lesions per RECIST criteria v1.1
- •Life expectancy greater than 12 weeks.
- •Adequate hematologic, hepatic, and renal function
- •Negative serum or urine pregnancy test for women of child bearing potential
排除标准
- •Prior therapy with an EGFR inhibitor or PD-1 or PD-L1 inhibitor in the recurrent or metastatic setting
- •Uncontrolled central nervous system metastases (stable metastases permitted)
- •Chemotherapy 28 days prior to first administration of study treatment and/or monoclonal antibody ≤8 weeks prior to first administration of study treatment.
- •History of other malignancies,
- •Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration of >10 mg/day of prednisone or equivalent)
- •Prior organ transplantation
- •Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).
研究组 & 干预措施
Avelumab, Palbociclib, and Cetuximab
Identify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab
干预措施: Avelumab (Drug)
Avelumab, Palbociclib, and Cetuximab
Identify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab
干预措施: Palbociclib (Drug)
Avelumab, Palbociclib, and Cetuximab
Identify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab
干预措施: Cetuximab (Drug)
结局指标
主要结局
maximum tolerated dose
时间窗: 12 months
maximum tolerated dose/recommended phase II dose.
次要结局
- Overall response rate(through study completion, an average of 3 years)
- progression free survival(through study completion, an average of 3 years)
- overall survival(through study completion, an average of 3 years)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](through study completion, an average of 3 years)
研究者
Kathryn Gold
Assistant Clinical Professor of Medicine
University of California, San Diego