Ipilimumab for treatment of advanced Merkel cell carcinoma

Ipilimumab 治疗晚期 Merkel 细胞癌

• 批准号: 8553195
• 负责人: Isaac Brownell
• 金额: $ 15.61万
• 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/8553195
• 关键词: Agreement; Biological Assay; Blood specimen; CTLA4 gene; Clinical; Clinical Research; Clinical Trials; FDA approved; Goals; Immune response; Immunotherapy; Label; Manufacturer Name; Mediation; Memorial Sloan-Kettering Cancer Center; Merkel cell carcinoma; Monitor; New York; Patients; Pharmaceutical Preparations; Phase; Protocols documentation; Reporting; Staging; United States National Institutes of Health; open label; response; tumor

This clinical trial is being developed to treat patients with advanced Merkel cell carcinoma (stage 3b or 4) off-label with the FDA-approved drug ipilimumab at the NIH Clinical Research Center and at Memorial Sloan-Kettering Cancer Center in New York. The manufacturer is supplying the drug, and a final agreement regarding the clinical trial is being negotiated with them. Concurrently the trial protocol is being developed and will soon undergo internal scientific review. Patients will be treated with ipilimumab and followed to monitor clinical response. In addition, tumor specimens and blood will be collected to evaluate anti-tumor immune responses during treatment.

这项临床试验正在开发，目的是在NIH临床研究中心和纽约的纪念斯隆凯特癌中心与FDA批准的药物ipilimumab脱离标签的晚期默克尔细胞癌（第3B或4期）患者。 制造商正在提供该药物，有关临床试验的最终协议正在与他们进行谈判。 同时正在制定试验方案，并将很快接受内部科学审查。 患者将接受ipilimumab治疗，并随后监测临床反应。 此外，将收集肿瘤标本和血液，以评估治疗过程中抗肿瘤免疫反应。