ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study: Safety, Toxicity and Immunological Effects of Peritumorally Delivered Immunotherapy in Early-stage Cervical Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
The ITHACA study is a phase I study evaluating the safety and toxicity of a peritumorally injected PD-1 checkpoint inhibitor, in combination with a multifunctional CTLA-4 inhibitor, in early-stage cervical cancer.
详细描述
In this single arm, open label phase I study, the investigators will study the safety and toxicity of the combination of a PD-1 checkpoint inhibitor and a multifunctional CTLA-4 inhibitor when injected peritumorally prior to surgery in early-stage cervical cancer. Additional objectives are to describe dose limiting toxicities, to determine the maximum tolerated doses and to study the effects on the tumor and lymph node microenvironment, and on immune subsets in peripheral blood.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •early-stage cervical cancer
- •scheduled for (radical) hysterectomy and pelvic lymph node dissection
排除标准
- •previous treatment with checkpoint inhibitors
- •use of immunosuppressive medication within 28 days of the injection of the study medication
- •history of other malignancy
研究组 & 干预措施
PD-1 checkpoint inhibitor and CTLA-4 inhibitor
Both antibodies will be peritumorally administered in early-stage cervical cancer prior to surgery.
干预措施: Anti-PD-1 antibody balstilimab (Drug)
结局指标
主要结局
Dose limiting toxicity
时间窗: 2 years
Type and severity of side effects according to CTCAE v 5.0.
次要结局
- Maximum tolerated dose(2 years)
研究者
C.H. (Stijn) Mom
Principle investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)