A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V-930 in Patients With Cancers Expressing HER-2 and/or CEA

Merck Sharp & Dohme LLC0 个研究点目标入组 26 人开始时间: 2005年9月最近更新: 2015年2月10日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 26

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.

研究设计

研究类型: Interventional
分配方式: Non Randomized
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

•Patients must have stages II, III, or IV breast, colorectal, ovaria, of non-small cell lung cancer
•Patients will either be disease free following primary therapy or have advanced disease with a durable response (>3 months) after standard therapy
•Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by Immunohistochemistry staining of the biopsies obtained from the primary tumor or metastasis

排除标准

•Patients with prior treatment with any HER-2 and/or CEA containing vaccine
•Patients who have significant cardiac disease
•Patients with autoimmune disorders
•Patients who are pregnant or lactating

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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