EUCTR2017-004570-34-DE进行中（未招募）1 期
Phase II, Open-label, Study in Patients with anaplastic (ATC) or poorly differentiated thyroid carcinomas (PDTC) to investigate the Clinical Efficacy and Safety of the Combination Therapy of Lenvatinib and Pembrolizumab - ATLEP
Medical Center - University of Freiburg0 个研究点目标入组 36 人开始时间: 2018年7月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female patients aged >18 years without upper age limit
- •2.Patient with histologically confirmed anaplastic or poorly differentiated thyroid carcinoma
- •3.At least one measurable target lesion according to irRECIST meeting the following criteria:
- •Lymph node (LN) lesion that measures at least 1 dimension as =1.5 cm in the short axis
- •Non-nodal lesion that measures =1.0 cm in the longest diameter
- •The lesion is suitable for repeat measurement using computerized tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence of disease progression based on irRECIST to be deemed a target lesion
- •4.ECOG performance status of 0-1
- •5.Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP =160/90 mmHg at screening and no change in antihypertensive medications within 1 week before registration.
- •6.Adequate renal function defined as creatinine =1.5xULN or calculated creatinine clearance =30 mL/min per the Cockcroft and Gault formula if creatinine level is >1.5xULN
- •7.Adequate bone marrow function defined by:
- •Absolute neutrophil count (ANC) =1,000/µL
- •Platelets =70,000/µL
- •Hemoglobin =8 g/dL
- •8.Adequate blood coagulation function defined by International Normalized ratio (INR) =1.5
- •9.Adequate liver function defined by:
- •Total bilirubin =1.5xULN except for unconjugated hyperbilirubinemia of Gilbert’s syndrome
- •Alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) =3 xULN (in the case of liver metastases =5xULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase. In case alkaline phosphatase is >3 xULN (in absence of liver metastases) or >5 xULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase
- •10.Written informed consent obtained according to international guidelines and local laws
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Patients who have previously received lenvatinib for more than four weeks or pembrolizumab or any other immune checkpoint inhibitor therapy (other kinase inhibitor therapies like sorafenib are permitted)
- •2.Patients with central nervous system (CNS) metastases, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 1 week before starting treatment in this study; any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 2 week before registration.
- •3.Active other malignancy within the last two years , which is not controlled by local or hormonal treatment (except for aromatase inhibitors).
- •4.Known intolerance to study drug (or any of the excipients)
- •5.Radiation therapy within 7 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions, which is allowed if completed one day prior to the first intake of lenvatinib.
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