A Phase 2, Multicenter, Randomized, Single-Blind Study of Vitespen (HSPPC-96, Oncophage) for Immune Response Assessment Following Treatment of Patients With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Agenus Inc.
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay
研究概览
简要总结
The primary objective of the study is to determine whether participants exhibit a measurable immune response after multiple administrations of HSPPC-96 (heat shock protein-peptide complex 96), as assessed by enzyme linked immunosorbent spot (ELISPOT) assay.
详细描述
The study consists of two parts: Part 1 with Part 1a (Assessment of Immune Variation) and Part 1b (Assay Standardization), and Part 2 (Immune Monitoring Study). The study was terminated early with 12 participants enrolled only in Part 1a and Part 1b. Part 2 of the study involved randomization after 8 doses of HSSPC-96. After the 8 doses of HSSPC-96 administered in Part 2, the participants were to be randomized to the treatment extension arm or the placebo extension arm. There were no participants enrolled in Part 2 since the study was terminated early. Therefore, no randomization occurred in the conduct of this study and only a single arm was enrolled.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of histological diagnosis of renal cell carcinoma (RCC) with evidence of >= 25% clear cell carcinoma
- •American joint committee on cancer tumor/node/metastasis tumor stage at intermediate risk for recurrence
- •At least 8 doses of vaccine available from participant's tumor
- •Life expectancy of at least 3 months
- •Eastern cooperative oncology group performance status of 0 or 1
- •Cardiovascular disease status of new york heart association class less than 2
- •Adequate hematopoietic, renal and hepatic function
- •Negative serology tests for human immunodeficiency virus (HIV), human T-cell lymphotrophic virus (HTLV-1), hepatitis B surface antigen (HBsAg), anti- hepatitis C virus antibodies (anti-HCV-Ab)
- •Females must have negative pregnancy test
排除标准
- •Evidence of metastatic or residual RCC
- •Documented radiological enlarged lymph nodes
- •Females who are pregnant or breastfeeding
- •Use of any other investigational product from 4 weeks post-surgery
- •Splenectomy performed during nephrectomy
结局指标
主要结局
Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay
时间窗: 6-7 weeks post surgery up to Week 14
The ELISPOT assay was not developed for this study and no immunogenicity data are available.
次要结局
未报告次要终点