A Phase I, Open Label, Single Arm, Single Centre Study to Evaluate Mechanism of Action of Talimogene Laherparepvec (T-VEC) in Locally Advanced Non-melanoma Skin Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change from Baseline local immune effects after repeated T-VEC injections
研究概览
简要总结
Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer.
详细描述
This study evaluates the administration of T-VEC in non-melanoma skin cancer. The aim is to evaluate the effectiveness, safety and tolerability of T-VEC in patients with non-melanoma skin cancer through determination of local immune effects after repeated T-VEC injections.
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
- •Subjects Age ≥ 18 years
- •histologically confirmed diagnosis of locally advanced squamous cell carcinoma, basal cell, carcinoma, Merkel cell carcinoma or cutaneous T cell lymphoma
- •at least 1 injectable cutaneous lesion ≥ 20 mm in longest Diameter or multiple injectable lesions that in Aggregate have a longest Diameter of ≥ 50 mm
- •Eastern Cooperative Oncology Group-Status (ECOG Status) 0 or 1
- •Adequate organ functions
排除标准
- •Hypersensitivity to T-VEC or any of ist components
- •Presence of organ and lymph node metastases
- •history or evidence of active autoimmune disease that requires systemic Treatment
- •Evidence of clinically significant immunosuppression
- •active herpetic skin lesions or prior complications hereof
- •pregnancy, breast feeding
- •requires intermittent or chronic systemic Treatment with an antiherpetic drug
- •acute or chronic active Hepatitis B or C infection or HIV infection
结局指标
主要结局
Change from Baseline local immune effects after repeated T-VEC injections
时间窗: at baseline, after 3 injections (week 6) and optionally after 6 injections (week 12)
Detection of increased local immune activation markers in skin biopsies of injected lesions. The following markers will be assessed by Polymerase chain reaction (PCR): interferon (IFN), 2-prime, 5-prime oligoadenylate synthetase 1 (OAS1), Interferon-induced GTP-binding protein MxA (MXA) and C-X-C motif chemokine 11 (CXCL11)
次要结局
- Analysis of Adverse events(At week 1, 4, 6, 8, 10, 12, 14, 16, 18, 22)
- Detection of Tumor Regression using World Health Organization (WHO) response criteria(at baseline and at week 22)
- Systemic immune response(at baseline and week 6, optionally also at week 12)