Pilot Study of Avelumab in Thymic Epithelial Tumors

Avelumab 在胸腺上皮肿瘤中的初步研究

• 批准号: 10262534
• 负责人: Arun Rajan
• 金额: $ 64.8万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10262534
• 关键词: B-Lymphocytes; Cell Count; Clinical; Clinical Trials; Enrollment; Evaluable Disease; Myocarditis; Myositis; Patients; Pilot Projects; Refractory; Relapse; Safety; Sicca Syndrome; Thymic Carcinoma; Thymoma; Thymus Epithelial Neoplasm; Thyroiditis; immune-related adverse events; objective response rate; partial response; response

Twenty-seven subjects (15 thymoma, 12 thymic carcinoma) have enrolled in this clinical trial and received treatment with Avelumab. Twenty-four subjects are evaluable for response. Four (17%) partial responses have been observed. Immune-related adverse events (irAEs) of any grade were observed in 12 (48%) patients and included myositis (17%), sicca syndrome (13%), myocarditis and thyroiditis (9% each). irAEs were generally manageable and resolved with appropriate therapy. Low baseline B-cell counts correlated with clinical response and occurrence of some irAEs.

27名受试者（15个胸腺瘤，12个胸腺癌）已参加该临床试验，并接受了AVELUMAB的治疗。可以评估二十四个受试者以进行反应。已经观察到了四个（17％）的部分反应。在12名（48％）患者中观察到与任何年级的免疫相关不良事件（IRAE），包括肌炎（17％），西卡综合征（13％），心肌炎和甲状腺炎（每个）。 IRAE通常是可以管理的，并通过适当的治疗解决。低基线B细胞计数与临床反应和某些IRAE的发生有关。