Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- immunological response of AFL and nivolumab as monotherapy and AFL+Nivolumab in BCC
研究概览
简要总结
The study aim is to assess the immunological and clinical response in basal cell carcinoma (BCC) treated with ablative fractionated laser (AFL) as monotherapy and compare with BCC treated with combination-therapy of AFL and the anti-PD1-drug nivolumab and with nivolumab as monotherapy.
详细描述
Explorative open label study. Patients and investigators are non-blinded and patients not randomized to interventions.
Three intervention groups:
- AFL monotherapy (8-10 patients)
- AFL+intratumoral nivolumab (8-10 patients)
- Intratumoral nivolumab monotherapy (8-10 patients)
Patients will attend 4 visits Immunological response is determined by immunohistochemistry (IHC) analysis from biopsies taken prior to AFL, AFL+Nivolumab or Nivolumab treatment (baseline) and compared with biopsies 1 week after treatment. Further, comparison of the immunological response of AFL monotherapy with immunological response AFL+Nivolumab and Nivolumab as monotherapy will be performed.
Patients included for AFL as monotherapy will after tumor demarcation receive AFL of the BCC including a 5 mm margin. An occlusive bandage will be applied to the treated area and is to be removed by the patient 24 hours after treatment or after end of secretion/oozing from the treated area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Patients 18 years or older
- •Clinical suspicion of BCC or histologically verified BCC at baseline and histologically verified BCC at visit 2, irrespective of histologic subtype with diameter ≥7 mm at baseline.
- •Signed informed consent.
- •Female subjects of childbearing potential* must be confirmed not pregnant by a negative pregnancy test prior to study treatment and must use a safe contraceptive method
排除标准
- •Concomitant treatment with 5-FU or imiquimod
- •Concomitant chemotherapeutic treatment
- •Concomitant systemic immunotherapeutic treatment, including Prednisolone
- •Pregnant or lactating women
- •Allergies to anti-PD1
- •Patients with a tendency to form keloids
- •Other skin diseases or tattoos in the treatment area
研究组 & 干预措施
AFL monotherapy
Singe dose AFL as monotherapy, 100 mJ
干预措施: Ablative fractionated laser (Device)
AFL+nivolumab
Single dose AFL 100 mJ followed by immediate intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor
干预措施: Nivolumab 10 MG/ML (Drug)
AFL+nivolumab
Single dose AFL 100 mJ followed by immediate intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor
干预措施: Ablative fractionated laser (Device)
nivolumab monotherapy
Intratumoral injection of nivolumab 10% 0.1 ml/cm2 tumor
干预措施: Nivolumab 10 MG/ML (Drug)
结局指标
主要结局
immunological response of AFL and nivolumab as monotherapy and AFL+Nivolumab in BCC
时间窗: 1 week
IHC as * CD8/CD3 ratio * CD4+Foxp3+/CD4 ratio
investigate the clinical response of AFL and Nivolumab as monotherapy and AFL+Nivolumab in BCC
时间窗: 12 weeks
evaluated by tumor reduction measured in mm and documented by clinical photos
次要结局
- Analysis and quantification of PD-L1 expression (tumor cells and TILs)(2 weeks)
- Detection of intra-tumoral Nivolumab(1 week)
- Tolerability of AFL, intratumoral nivolumab and AFL+Nivolumab(12 weeks)
研究者
Silje Haukali Omland
Principal Investigator
Bispebjerg Hospital