VENTANA PD-L1 (SP142), a complimentary diagnostic immunohistochemistry (IHC) assay to ascertain tumor PD-L1 status for patients with metastatic urothelial cancer considering treatment with atezolizuma

VENTANA PD-L1 (SP142)，一种免费的诊断性免疫组织化学 (IHC) 检测，用于确定考虑使用 atezolizuma 治疗的转移性尿路上皮癌患者的肿瘤 PD-L1 状态

• 批准号: 10038613
• 负责人: LEONARD FREEDMAND
• 金额: $ 10万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-31 至 2020-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10038613
• 关键词: Antibodies; Area; Biological Assay; Biopsy; Clonality; Diagnostic; Human; Immune; Immunohistochemistry; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Oryctolagus cuniculus; PDCD1LG1 gene; PPBP gene; Patients; Positive Lymph Node; Protocols documentation; Radiation; Radiation therapy; Sampling; T-Cell Receptor; Tumor-infiltrating immune cells; anti-PD-L1; blood treatment; chemoradiation; immune function; neoplastic cell; peripheral blood; primary endpoint; response; tumor

Abstract NCI Protocol: NRG-GY017 “Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently with Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical Cancer.” Briefly, PD-L1 expression will be assessed using the rabbit anti-human PD-L1 antibody (clone SP142). Using IHC, PD-L1 expression will be scored in tumor cells (as percentage of PD-L1-expressing tumor cells: TC3≥50%, TC2≥5% and <50%, TC1≥1% and <5%, and TC0<1%) and tumor infiltrating immune cells (as percentage of tumor area: IC3≥10%, IC2≥5% and <10%, IC1≥1% and <5%, and IC0<1%). To satisfy the primary objective of the study, the following will be assessed in response to sequential versus concurrent atezolizumab and radiation: (1) peripheral blood T Cell Receptor (TCR) clonality, and (2) peripheral blood expansion of TCR clones, including TCR clones identified in tumor samples. For assessment of the primary endpoint, pre-treatment FFPE tumor biopsies (to determine which TCR clones are present within the tumor), as well as pre-treatment and on-treatment bloods will be required.

摘要 NCI方案：NRG-GY 017“抗PD-L1（Atezolizumab）作为免疫引物，并同时与淋巴结阳性局部晚期宫颈癌的扩展野放化疗。” 简言之，将使用兔抗人PD-L1抗体（克隆SP142）评估PD-L1表达。使用IHC，对肿瘤细胞（表达PD-L1的肿瘤细胞百分比：TC 3 ≥ 50%，TC 2 ≥5%且<50%，TC 1 ≥1%且<5%，以及TC 0 <1%）和肿瘤浸润免疫细胞（肿瘤面积百分比：IC 3 ≥ 10%，IC 2 ≥5%且<10%，IC 1 ≥1%且<5%，以及IC 0 <1%）中的PD-L1表达进行评分。 为了满足研究的主要目的，将评估以下对依序与同时atezolizumab和放射的反应：（1）外周血T细胞受体（TCR）克隆性，和（2）TCR克隆的外周血扩增，包括肿瘤样本中鉴定的TCR克隆。 对于主要终点的评估，将需要治疗前FFPE肿瘤活检（以确定肿瘤内存在哪些TCR克隆）以及治疗前和治疗中的血液。