NYU Melanoma SPORE

整体项目总结 在过去的十年中，免疫检查点抑制(ICI)疗法取得了令人印象深刻的临床成功，但 与之相匹配的是临床上有用的工具的开发，以预测患者的反应和毒性。这个 将患者结局和毒性的生物标记物整合到临床护理中将允许更理想的治疗 选择。纽约大学(NYU)黑色素瘤孢子的主要目标是解决 迫切需要开发和验证临床上有用的个性化生物标记物，以最佳地给药 佐剂环境下的免疫检查点抑制疗法。我们选择集中力量 在这一领域，因为FDA在这一临床背景下批准免疫疗法导致了 利用这些治疗方法，将辅助试验扩大到其他癌症。使用ICI佐剂将 改变黑色素瘤和其他恶性肿瘤的免疫生物学。识别有益的生物标志物和 毒性是关键的、及时的，并有望具有广泛的适用性。我们所有的项目都进行了修订，以反映这一点 调整重点，使总体规划目标更具凝聚力、可实现性和影响力。 开发新的生物标记物需要分阶段进行。纽约大学黑色素瘤孢子包括项目 从靶标识别和临床相关性(项目1、2、3、4)跨越生物标记物开发路径， 分析和临床验证(项目3、4)，并最终在研究人员发起的测试中实现临床效用 临床试验(项目3)。纽约大学的黑色素瘤孢子特别适合实现这一目标，因为 我们广泛的患者基础和我们在生物标记物识别和开发方面的翻译专业知识。内科医生 在纽约大学朗格尼健康中心(NYULH)，每年治疗1000多名新的黑色素瘤患者。作为旗舰研究 NCI资助的纽约大学珀尔穆特癌症中心(PCC)的计划，我们的黑色素瘤翻译研究计划 在黑色素瘤生物标记物开发方面有既定的合作记录和高影响力的发现， 由NYULH治疗的3,800多名患者提供丰富的生物样品资源，这些资源和 广泛的机构基础设施和能力将使纽约大学黑色素瘤孢子能够表征 用于黑色素瘤患者临床管理的新型个性化生物标志物。它们的范围和可伸缩性 资源将扩展到我们对2700名黑色素瘤患者的研究，这些患者参加了第三阶段的多点临床试验 佐剂设置(将死238、将死915和基调716)。纽约大学黑色素瘤孢子 PD/PIs，Iman Osman博士和Jeffrey Weber博士，在黑色素瘤ICI药物方面合并互补专业知识 开发、临床试验和生物标记物研究。我们将发挥我们的优势，解决中国的紧迫需求 黑色素瘤领域，可以扩展到越来越多的ICI治疗的癌症。

OVERALL PROJECT SUMMARY The impressive clinical successes in immune checkpoint inhibition (ICI) therapy over the last decade have not been matched by the development of clinically useful tools to predict patient response and toxicity. The integration of biomarkers of patient outcome and toxicity into clinical care would allow more optimal treatment selection. The primary objective of the New York University (NYU) Melanoma SPORE is to address the urgent need to develop and validate clinically useful, personalized biomarkers to optimally administer immune checkpoint inhibition therapies in the adjuvant setting. We have chosen to concentrate our efforts in this area because FDA approval of immunotherapies in this clinical context has led to a significant increase in the utilization of these treatments with expansion of adjuvant trials to other cancers. The use of adjuvant ICI will alter the immunobiology of melanoma and other malignancies as well. Identifying biomarkers of benefit and toxicity is critical, timely, and promises to have broad applicability. All of our projects were revised to reflect this adjusted focus, making the goals of the overall program more cohesive, achievable, and impactful. The development of new biomarkers requires a phased approach. The NYU Melanoma SPORE includes projects that span the biomarker development path from target identification and clinical relevance (Projects 1, 2, 3, 4), to assay and clinical validation (Projects 3, 4), and ultimately clinical utility with testing in an investigator-initiated clinical trial (Project 3). The NYU Melanoma SPORE is particularly well suited to achieve this objective due to our broad patient base and our translational expertise in biomarker identification and development. Physicians at NYU Langone Health (NYULH) treat over 1,000 new melanoma patients annually. As a flagship research program of the NCI-funded NYU Perlmutter Cancer Center (PCC), our melanoma translational research program has an established track record of collaboration and high impact findings in melanoma biomarker development, empowered by rich biospecimen resources from over 3,800 patients treated at NYULH These resources and extensive institutional infrastructure and capabilities will enable the NYU Melanoma SPORE to characterize novel personalized biomarkers for melanoma patient clinical management. The scope and scalability of these resources will extend to our studies of 2,700 melanoma patients enrolled in phase III, multisite clinical trials in the adjuvant setting (CheckMate 238, CheckMate 915 and KEYNOTE 716). The NYU Melanoma SPORE PD/PIs, Drs. Iman Osman and Jeffrey Weber, merge complementary expertise in melanoma ICI drug development, clinical trials, and biomarker investigations. We will apply our strengths to solve pressing needs in the melanoma field which which can be extended to the increasing number of ICI--treated cancers.