Purpose: Immunoprofiling to identify biomarkers and integration with clinical trial outcomes are critical to improving immunotherapy approaches for patients with cancer. However, the translational potential of individual studies is often limited by small sample size of trials and the complexity of immuno-oncology biomarkers. Variability in assay performance further limits comparison and interpretation of data across studies and laboratories. Experimental Design: To enable a systematic approach to biomarker identification and correlation with clinical outcome across trials, the Cancer Immune Monitoring and Analysis Centers and Cancer Immunologic Data Commons (CIMAC-CIDC) Network was established through support of the Cancer MoonshotSM Initiative of the National Cancer Institute (NCI) and the Partnership for Accelerating Cancer Therapies (PACT) with industry partners via the Foundation for the NIH. Results: The CIMAC-CIDC Network is composed of four academic centers with multidisciplinary expertise in cancer immunotherapy that perform validated and harmonized assays for immunoprofiling and conduct correlative analyses. A data coordinating center (CIDC) provides the computational expertise and informatics platforms for the storage, integration, and analysis of biomarker and clinical data. Conclusions: This overview highlights strategies for assay harmonization to enable cross-trial and cross-site data analysis and describes key elements for establishing a network to enhance immuno-oncology biomarker development. These include an operational infrastructure, validation and harmonization of core immunoprofiling assays, platforms for data ingestion and integration, and access to specimens from clinical trials. Published in the same volume are reports of harmonization for core analyses: whole-exome sequencing, RNA sequencing, cytometry by time of flight, and IHC/immunofluorescence.

中文翻译：

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用于癌症免疫治疗的生物标志物免疫分析网络：癌症免疫监测和分析中心和癌症免疫数据共享 (CIMAC-CIDC)

目的：用于识别生物标志物的免疫分析以及与临床试验结果的整合对于改进癌症患者的免疫治疗方法至关重要。然而，个别研究的转化潜力通常受到试验样本量小和免疫肿瘤生物标志物复杂性的限制。分析性能的可变性进一步限制了研究和实验室之间数据的比较和解释。实验设计：为了实现生物标志物识别的系统方法以及与临床结果相关性的跨试验，癌症免疫监测和分析中心和癌症免疫数据共享 (CIMAC-CIDC) 网络是在国家癌症研究所 (NCI) 的癌症登月计划以及与行业合作伙伴的加速癌症治疗伙伴关系 (PACT) 的支持下建立的美国国立卫生研究院基金会。结果：CIMAC-CIDC 网络由四个在癌症免疫治疗方面具有多学科专业知识的学术中心组成，这些中心执行经过验证和协调的免疫分析检测并进行相关分析。数据协调中心 (CIDC) 为生物标志物和临床数据的存储、集成和分析提供计算专业知识和信息学平台。结论：本概述重点介绍了用于实现跨试验和跨站点数据分析的检测协调策略，并描述了建立网络以增强免疫肿瘤学生物标志物开发的关键要素。其中包括运营基础设施、核心免疫分析检测的验证和协调、数据摄取和整合平台以及从临床试验中获取样本。在同一卷中发表了核心分析的协调报告：全外显子组测序、RNA 测序、飞行时间流式细胞术和 IHC/免疫荧光。并获得来自临床试验的标本。在同一卷中发表了核心分析的协调报告：全外显子组测序、RNA 测序、飞行时间流式细胞术和 IHC/免疫荧光。并获得来自临床试验的标本。在同一卷中发表了核心分析的协调报告：全外显子组测序、RNA 测序、飞行时间流式细胞术和 IHC/免疫荧光。