Measurement of PD-L1 Expression in Cancer to Monitor Treatment Response.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.
研究概览
简要总结
Measurement of PD-L1 expression in cancer to monitor treatment response.
A prospective non-blinded, single centre, single interventional arm diagnostic imaging study.
To determine the baseline level and variability within and between patients and tumour types of PD-L1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve patients using [99mTc]-anti-PD-L1 SPECT/CT and immunohistochemistry.
详细描述
Using [99mTc]-labeled anti-PD-L1 single-domain antibody, this study aims to prospectively measure changes in PD-L1 expression determined with SPECT/CT imaging and correlate these changes with response to anti-PD(L)1 immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Aged 18 or above
- •Patients with histologically confirmed NSCLC or melanoma scheduled for PD1/PDL1 immunotherapy alone or in combination with other systemic anti-cancer therapy.
- •Willingness and ability to comply with scheduled study visits and tests.
排除标准
- •Pregnant or lactating women
- •Concomitant uncontrolled medical conditions
- •Patients likely to require palliative radiotherapy within the first 12 weeks of treatment or radiotherapy to target lesion(s) received within preceding 42 days
- •More than 3 months between IHC PDL1 and study recruitment
- •Patients who have received other systemic anti-cancer therapy within preceding 14 days
- •Prognosis less than 3 months
- •Previous anticancer treatment with any checkpoint inhibitor or other immunotherapy, i.e. only immunotherapy naïve patients
研究组 & 干预措施
Advanced malignant disease (non-small cell lung cancer or malignant melanoma)
Group 1: Participants with non-small cell lung cancer (NSCLC) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 9 weeks.
FDG-PET/CT is also performed at baseline (0) and first follow-up (9) weeks scans, in addition to standard CT clinical imaging at 0, 9 and 18 weeks.
Group 2: Participants with malignant melanoma (MM) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 12 weeks.
FDG-PET/CT is also performed as standard clinical imaging at baseline (0), first follow-up (12) weeks and 24 weeks.
干预措施: [99mTc]-NM-01 SPECT/CT (Diagnostic Test)
结局指标
主要结局
Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.
时间窗: Up to 18 weeks
PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of \[99mTc\]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 9 weeks will be compared to determine % change. Standard clinical imaging assessment at 9 and 18 weeks used as comparators.
Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions.
时间窗: Up to 24 weeks
PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of \[99mTc\]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 12 weeks will be compared to determine % change. Standard clinical imaging assessment at 12 and 24 weeks used as comparators.
次要结局
- Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry.(Baseline)