Phase 2 Study of Nivolumab Plus Lenvatinib for Patients With Unresectable Anaplastic Thyroid Cancer (NAVIGATION Study)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
- 试验地点
- 10
- 主要终点
- Step 2: Objective Response Rate (ORR)
研究概览
简要总结
This study is an open-label phase 2 study to evaluate the safety and efficacy of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer.
详细描述
This study is an open-label phase 2 study to evaluate the safety and efficacy of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer according to the following steps.
Step 1 will evaluate the dose-limiting toxicities (DLT) of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer.
Step 2 will evaluate the safety and efficacy of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed as anaplastic thyroid cancer
- •Unresectable anaplastic thyroid cancer
- •Have measurable lesions defined by the RECIST version 1.1
- •Have adequate organ function
- •Cardiac function test within 28 days before enrollment 12-lead electrocardiogram no clinically significant abnormality as shown below: heart disease, severe arrhythmia, etc.
- •Patients who are 20 years or older
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Ability to swallow oral medications
- •Women of childbearing potential
- •Life expectancy of more than 90 days
- •Have signed written informed consent to participate in this study
排除标准
- •Active brain metastases or leptomeningeal metastases
- •Diverticulitis or Symptomatic ulcerative disease
- •Treatment required complication of systemic infectious disease
- •Medical history of active, known, or suspected autoimmune disease
- •Complication of pulmonary fibrosis or interstitial pneumonitis
- •Medical history of clinically significant cardiovascular disease within 180 days of initial dose as New York Heart Association (NYHA) class above 2 leveled congestive heart failure, unstable angina, cardiac infarction or cardiac arrhythmia with paroxysmal or required treatment
- •Regardless of usage of antihypertensive drug, systolic blood pressure <=140 mm Hg and diastolic blood pressure <=90 mm Hg
- •Have active double cancer
- •Currently receiving other interventional clinical study treatment
研究组 & 干预措施
Lenvatinib plus Nivolumab
Step 1: 3 patients, Step 2: 48 patients
干预措施: Lenvatinib (Drug)
Lenvatinib plus Nivolumab
Step 1: 3 patients, Step 2: 48 patients
干预措施: Nivolumab (Drug)
结局指标
主要结局
Step 2: Objective Response Rate (ORR)
时间窗: Up to 12 months
ORR will be defined as the proportion of patients achieving complete response (CR) and partial response (PR) as determined according to RECIST ver1.1 by a central review
Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT)
时间窗: up to 28 days
Proportion of subjects with DLT will be defined as the proportion of patients who developed DLT
次要结局
- Proportion of adverse events(Up to 12 months)
- Progression-Free Survival (PFS)(Up to 12 months)
- Quality of life by EuroQol 5 dimensions 5-level (EQ-5D-5L)(Up to 12 months)
- Overall Survival (OS)(Up to 12 months)
- Disease Control Rate (DCR)(Up to 12 months)
- Best Overall Response (BOR)(Up to 12 months)
- Clinical Benefit Rate (CBR)(Up to 12 months)
研究者
Makoto Tahara
Chief, Department of Head and Neck Medical Oncology
National Cancer Center Hospital East