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: 10273221
• 负责人: LEONARD FREEDMAN
• 金额: $ 20万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-31 至 2021-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10273221
• 关键词: Area; Biological Assay; Biopsy; Diagnostic; Human; Immune; Immunohistochemistry; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Oryctolagus cuniculus; PPBP gene; Patients; Positive Lymph Node; Protocols documentation; Radiation; Radiation therapy; Sampling; T cell clonality; T-Cell Receptor; Tumor-infiltrating immune cells; Urothelium; anti-PD-L1; anti-PD-L1 antibodies; blood treatment; chemoradiation; immune function; neoplastic cell; peripheral blood; primary endpoint; programmed cell death ligand 1; response; tumor

"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."

NCI方案：NRG-GY017“抗PD-L1 （Atezolizumab）作为免疫引物并同时用于淋巴结阳性局部晚期宫颈癌的扩展野放化疗。”