Multicenter, Single-arm, Phase II Study of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intra- and Postoperatively in Patients With Epithelial Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- the rate of all specific postoperative complications newly observed during a period of 30 days after surgery
研究概览
简要总结
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.
详细描述
An open label, multi-center, single-arm, phase II study according to Fleming´s one-stage design. The surgical procedure on Day 0 will be performed according to AGO State of the Art, followed by one intraoperative and four postoperative intraperitoneal administrations of catumaxomab within 16 days. The Discharge Visit will be performed when the patient is leaving the hospital but not earlier than 1 day after the last infustion, followed by the End of Study Visit on Day 30.
Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •signed and dated informed consent form before any protocol-specific screening procedures
- •patients has a primary diagnosis of an epithelial ovarian cancer including clear cell carcinoma (FIGO IA(G2-G3) - IV)
- •Karnofsky index > or equal 70
- •female at an age of 18 years or older
- •negative pregnancy test
排除标准
- •exposure to prior cancer therapy specific for ovarian cancer
- •previos treatment with non-humanized mouse or rat monoclonal antibodies
- •known / suspected hypersensitivity to catumaxomab or similar antibodies
- •second malignangcy within the last 5 years
- •presence of constant immunosuppressive therapy
- •presence of symptomatic heart failure or occlusive arterial diseases
- •inadequate renal or hepatic function
- •presence of any acute or chronic systemic infection
研究组 & 干预措施
1
干预措施: Catumaxomab (Drug)
结局指标
主要结局
the rate of all specific postoperative complications newly observed during a period of 30 days after surgery
时间窗: 30 days after surgery
次要结局
- safety and efficacy endpoints(EOS is on day 30, post study period additional 23 months)