CT223:癌症疫苗试验平台的构建:NHS英格兰癌症疫苗发射台(CVLP)

IF 12.5 1区 医学 Q1 ONCOLOGY
Gareth Griffiths, Victoria Goss, Nicole Keyworth, Daniel Muller, Sam Wilding, Simon Crabb, Emily Shaw, Nicola Chapman-Hart, Max Shen, Patrick Ezeani, Gillian Rosenberg, Peter Johnson
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Methods: The CVLP aims to rapidly identify large numbers of cancer patients who could be eligible for trials to expedite evidence for the efficacy of vaccines across multiple types of cancer. To support the identification of participants their tissue samples are processed by a standardised, high quality, expanded pathway, incorporating elements of the NHS Genomic Medicine Service. The primary objective of the CVLP is to determine whether it is feasible to recruit cancer patients to a platform for personalised cancer vaccine trials, whether there is capacity for tumor samples to be analysed within a suitable time frame and if this results in acceptable participation in cancer vaccine clinical trials. Sponsored by NHS England the first trial incorporated within the CVLP is BioNTech BNT122-01 (NCT04486378) investigating the RO7198457 mRNA vaccine in patients with ctDNA-positive, resected Stage II/III colorectal cancer. Results: Between Sep 2023 and Dec 2024, 435 patients have consented to participate in the CVLP from 55 English sites, 96.4% of tissue samples were prepared in the required time frame for testing (average 2.5 days), of which 342 patients proceeded to referral to BNT122-01. We now estimate that approximately 60% of patients across England undergoing colorectal surgery have access to the trial through the CVLP resulting in the UK screening more than 3x the global average for BNT122-01 trial. 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引用次数: 0

摘要

背景:建立 CVLP 的目的是通过招募合适的患者和支持加速肿瘤组织处理来解决大规模生成个性化疫苗的过程。CVLP 是一个合作项目,包括英国国家医疗服务系统(NHS)、英国基因组学协会(Genomics England)、英国卫生与社会关怀部(Department of Health and Social Care)、英国生命科学办公室(Office for Life Sciences)和英国国家卫生与关怀研究所(NIHR),由英国癌症研究中心南安普顿临床试验组(Cancer Research UK Southampton Clinical Trials Unit)负责实施。CVLP 是一项与公司和试验无关的计划,因此可以灵活适应多种癌症类型的多种癌症疫苗试验的需要。方法:CVLP 的目的是快速确定大量符合试验条件的癌症患者,以加速证明疫苗在多种癌症类型中的疗效。为支持参与人员的鉴定工作,他们的组织样本将通过标准化、高质量、扩展的途径进行处理,并纳入英国国家医疗服务系统基因组医学服务的元素。CVLP 的主要目标是确定在个性化癌症疫苗试验平台上招募癌症患者是否可行,是否有能力在适当的时间框架内对肿瘤样本进行分析,以及这样做是否会导致癌症疫苗临床试验的可接受性。在英国国家医疗服务系统(NHS)的赞助下,纳入 CVLP 的第一项试验是 BioNTech BNT122-01 (NCT04486378),该试验调查了 RO7198457 mRNA 疫苗在ctDNA 阳性、切除的 II/III 期结直肠癌患者中的应用情况。研究结果从 2023 年 9 月到 2024 年 12 月,来自 55 个英国研究机构的 435 名患者同意参与 CVLP,96.4% 的组织样本在规定时间内(平均 2.5 天)制备完成,其中 342 名患者转诊至 BNT122-01。我们现在估计,全英格兰约有60%接受结直肠手术的患者可以通过CVLP获得试验机会,因此英国的BNT122-01试验筛查率是全球平均水平的3倍多。CVLP 患者路径从患者识别到进入可用临床试验的整个过程都是在可行性研究阶段开发的,目前包括以下步骤:i) 由管理患者护理的临床团队识别患者并同意其加入 CVLP;ii) 收集血液和组织样本(手术期间);iii) 将样本送至细胞病理学基因组中心和基因组实验室进行基因组测序;iv) 将测序数据作为国家医疗服务体系护理标准的一部分进行存储,临床联络团队将患者与可用的研究试验配对。目前,CVLP 已着手在其他癌症适应症中开展更多癌症疫苗试验。结论:CVLP已达到招募300名患者的首个可行性终点,并已着手开展更多癌症疫苗试验。引用格式:Gareth Griffiths、Victoria Goss、Nicole Keyworth、Daniel Muller、Sam Wilding、Simon Crabb、Emily Shaw、Nicola Chapman-Hart、Max Shen、Patrick Ezeani、Gillian Rosenberg、Peter Johnson。癌症疫苗试验平台的建立:英国国家医疗服务系统癌症疫苗启动平台(CVLP)[摘要]。In:美国癌症研究协会 2025 年年会论文集;第 2 部分(晚期突破、临床试验和特邀);2025 年 4 月 25-30 日;伊利诺伊州芝加哥。费城(宾夕法尼亚州):AACR; Cancer Res 2025;85(8_Suppl_2): nr CT223.
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Abstract CT223: The building of a cancer vaccine trial platform: The NHS England Cancer Vaccine Launch Pad (CVLP)
Background: The CVLP has been established to address the process for generating personalized vaccines at scale, by recruiting suitable patients and supporting accelerated tumor tissue processing. The CVLP is a collaborative project including NHS England, Genomics England, the Department of Health and Social Care, the Office for Life Sciences and the National Institute of Health and Care Research (NIHR) which is being delivered by the Cancer Research UK Southampton Clinical Trials Unit. The CVLP has been designed as a company and trial agnostic program so it can be flexible to the needs of multiple cancer vaccine trials in multiple cancer types. Methods: The CVLP aims to rapidly identify large numbers of cancer patients who could be eligible for trials to expedite evidence for the efficacy of vaccines across multiple types of cancer. To support the identification of participants their tissue samples are processed by a standardised, high quality, expanded pathway, incorporating elements of the NHS Genomic Medicine Service. The primary objective of the CVLP is to determine whether it is feasible to recruit cancer patients to a platform for personalised cancer vaccine trials, whether there is capacity for tumor samples to be analysed within a suitable time frame and if this results in acceptable participation in cancer vaccine clinical trials. Sponsored by NHS England the first trial incorporated within the CVLP is BioNTech BNT122-01 (NCT04486378) investigating the RO7198457 mRNA vaccine in patients with ctDNA-positive, resected Stage II/III colorectal cancer. Results: Between Sep 2023 and Dec 2024, 435 patients have consented to participate in the CVLP from 55 English sites, 96.4% of tissue samples were prepared in the required time frame for testing (average 2.5 days), of which 342 patients proceeded to referral to BNT122-01. We now estimate that approximately 60% of patients across England undergoing colorectal surgery have access to the trial through the CVLP resulting in the UK screening more than 3x the global average for BNT122-01 trial. The CVLP patient pathway from patient identification to entry into available clinical trials has been developed during the feasibility stage which now includes following the steps; i) patients identified by the clinical team managing their care and consented into CVLP; ii) blood and tissue samples (during surgery) collected; iii) samples sent to Cellular Pathology Genomic Centre and Genomic Laboratory Labs to carry out genomic sequencing; iv) sequencing data stored as part of NHS standard of care and the clinical liaison team pairs patients with available research trials. The CVLP has now progressed to onboarding further cancer vaccine trials in other cancer indications. Conclusions: CVLP has met its first feasibility endpoint of recruiting 300 patients and has progressed to onboarding further cancer vaccine trials. Citation Format: Gareth Griffiths, Victoria Goss, Nicole Keyworth, Daniel Muller, Sam Wilding, Simon Crabb, Emily Shaw, Nicola Chapman-Hart, Max Shen, Patrick Ezeani, Gillian Rosenberg, Peter Johnson. The building of a cancer vaccine trial platform: The NHS England Cancer Vaccine Launch Pad (CVLP) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited s); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2): nr CT223.
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来源期刊
Cancer research
Cancer research 医学-肿瘤学
CiteScore
16.10
自引率
0.90%
发文量
7677
审稿时长
2.5 months
期刊介绍: Cancer Research, published by the American Association for Cancer Research (AACR), is a journal that focuses on impactful original studies, reviews, and opinion pieces relevant to the broad cancer research community. Manuscripts that present conceptual or technological advances leading to insights into cancer biology are particularly sought after. The journal also places emphasis on convergence science, which involves bridging multiple distinct areas of cancer research. With primary subsections including Cancer Biology, Cancer Immunology, Cancer Metabolism and Molecular Mechanisms, Translational Cancer Biology, Cancer Landscapes, and Convergence Science, Cancer Research has a comprehensive scope. It is published twice a month and has one volume per year, with a print ISSN of 0008-5472 and an online ISSN of 1538-7445. Cancer Research is abstracted and/or indexed in various databases and platforms, including BIOSIS Previews (R) Database, MEDLINE, Current Contents/Life Sciences, Current Contents/Clinical Medicine, Science Citation Index, Scopus, and Web of Science.
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