NCT03110445撤回1 期
Monocentric Open Label Phase I Immunotherapy Trial of Breast Cancer Patients With a Non-replicating Recombinant Vaccinia Virus Expressing Cancer/Testis Antigens and Cluster of Differentiation Antigen 80 (CD80)-CD40L Costimulatory Molecules.
University Hospital, Basel, Switzerland0 个研究点开始时间: 2020年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- number of adverse Events
研究概览
简要总结
Monocentric open-label phase I/II trial aiming at evaluating, in adjuvant setting, safety (primary outcome), immunological and clinical efficacy (secondary outcomes) of a non replicating recombinant vaccinia virus expressing cancer/testis antigen (CTA) derived epitopes and CD80 and CD40 ligand (CD40L, CD154) costimulatory molecules in patients with CTA expressing tumors.
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
- •Surgically treated M0 patients with solid tumors
- •Tumor expressing at least one of the vaccine targeted antigens Melanoma-associated antigen (MAGE)-A1, -A2,
- •A3, -A4, -A6, -A10, -A12 or New York (NY) esophageal squamous cell carcinoma-1 (ESO-1) (NY-ESO-1) (by real-time quantitative PCR (RT-qPCR))
- •Patient expressing the targeted Human Leukocyte Antigen (HLA) restriction (A0201 /A0101/ B3501)
- •4 weeks interval following surgical resection of tumor and, if applicable, completion of adjuvant therapy.
- •Karnofsky over 70%
- •No other concomitant malignancy
排除标准
- •History of anaphylaxis or severe allergic reaction
- •Severe heart, lung, kidney, liver or psychiatric condition
- •Concurrent immunosuppressive therapy or impaired immune system
结局指标
主要结局
number of adverse Events
时间窗: 2 years
Safety measured by assessment of number of adverse events that have occured
number of serious adverse Events
时间窗: 2 years
Safety measured by assessment of number of serious adverse Events that have occured
次要结局
- Evolution of Immune reactivity to the CTA(18 months)
- Disease free survival(2 years)
- Overall survival(2 years)
研究者
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