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

摘要 NCI方案：NRG-GY017“抗PD-L1(Atezolizumab)作为免疫底物，同时配合扩大野放化疗治疗结节阳性局部晚期宫颈癌。 简而言之，将使用兔抗人PD-L1抗体(克隆SP142)来评估PD-L1的表达。免疫组化检测PD-L1在肿瘤细胞和肿瘤浸润性免疫细胞中的表达情况(肿瘤细胞表达PD-L1的百分比分别为Tc3≥50%，Tc2≥5%，Tc2≥5%，Tc0≥；1%)和肿瘤浸润性免疫细胞(肿瘤面积百分比：Ic3≥10%，Ic2≥5%，Ic0；lt；1%)。 为了满足这项研究的主要目标，将对以下连续和同时进行的阿替唑珠单抗和放射反应进行评估：(1)外周血T细胞受体(TCR)克隆性，以及(2)TCR克隆体的外周血液扩张，包括在肿瘤样本中发现的TCR克隆体。 对于主要终点的评估，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将是必需的。

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.