NYU Melanoma SPORE

纽约大学黑色素瘤孢子

• 批准号: 10652334
• 负责人: Iman Osman
• 金额: $ 208.42万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-19 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10652334
• 关键词: Achievement; Address; Adjuvant; Adjuvant Study; Adjuvant Therapy; Area; Biological Assay; Biological Markers; Blood specimen; CD4 Positive T Lymphocytes; CD8B1 gene; Cancer Center; Cancer Center Support Grant; Caring; Clinic; Clinical; Clinical Data; Clinical Management; Clinical Trials; Collaborations; DNA; Data; Development; Diagnostic tests; Discipline; Disease; Eligibility Determination; Enrollment; Environment; Faculty Recruitment; Fostering; Funding; Goals; Health; Health Resources; Immune; Immunobiology; Immunologic Adjuvants; Immunotherapy; Infrastructure; Inherited; Institution; Investigation; Investments; Malignant Neoplasms; MicroRNAs; Multi-Institutional Clinical Trial; New York; Outcome; Patient-Focused Outcomes; Patients; Performance; Phase; Physicians; Placebos; Prognosis; Prognostic Marker; Randomized; Relapse; Research; Research Personnel; Resected; Resources; Sampling; Scientist; Selection for Treatments; Severities; Solid; Testing; Toxic effect; Translational Research; Underrepresented Minority; Universities; Update; Validation; Variant; Woman; base; biomarker development; biomarker identification; biomarker validation; career; checkpoint inhibition; clinical biomarkers; clinical care; clinical development; clinically relevant; drug development; empowerment; experience; genetic variant; high risk; improved; innovation; melanoma; melanoma biomarkers; member; novel; novel marker; optimal treatments; participant enrollment; patient biomarkers; patient response; peripheral blood; predictive marker; predictive tools; prognostic tool; programs; recruit; relapse prediction; response; stool sample; success; survival prediction; therapy development; tool; translational research program; tumor

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.

项目总体概要 过去十年中免疫检查点抑制（ICI）疗法取得的令人印象深刻的临床成功并没有 与预测患者反应和毒性的临床有用工具的开发相匹配。这 将患者结果和毒性的生物标志物整合到临床护理中将实现更优化的治疗 选择。纽约大学 (NYU) 黑色素瘤 SPORE 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志物以实现最佳给药 辅助环境中的免疫检查点抑制疗法。我们选择集中精力 在这一领域，因为 FDA 批准在这一临床背景下的免疫疗法导致了 利用这些治疗方法并将辅助试验扩展到其他癌症。使用 ICI 佐剂将 也改变黑色素瘤和其他恶性肿瘤的免疫生物学。识别益处和生物标志物 毒性是至关重要的、及时的，并且有望具有广泛的适用性。我们所有的项目都进行了修改以反映这一点 调整重点，使整个计划的目标更具凝聚力、可实现性和影响力。 新生物标志物的开发需要分阶段的方法。纽约大学黑色素瘤 SPORE 包括项目 跨越从目标识别到临床相关性的生物标记物开发路径（项目 1、2、3、4）， 进行分析和临床验证（项目 3、4），并最终通过研究者发起的测试进行临床应用 临床试验（项目3）。纽约大学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以及我们在生物标志物识别和开发方面的转化专业知识。医生 纽约大学朗格健康中心 (NYULH) 每年治疗 1,000 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) 项目，我们的黑色素瘤转化研究项目 在黑色素瘤生物标志物开发方面拥有良好的合作记录和高影响力的发现， 得益于来自 NYULH 超过 3,800 名患者的丰富生物样本资源 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。这些的范围和可扩展性 资源将扩展到我们对 2,700 名黑色素瘤患者进行的研究，这些患者参加了 III 期多中心临床试验 辅助设置（CheckMate 238、CheckMate 915 和 KEYNOTE 716）。纽约大学黑色素瘤孢子 PD/PI、博士。 Iman Osman 和 Jeffrey Weber 合并黑色素瘤 ICI 药物方面的互补专业知识 开发、临床试验和生物标志物研究。我们将发挥所长，解决燃眉之急 黑色素瘤领域可以扩展到越来越多的 ICI 治疗癌症。

项目成果

Impact of molecular testing in advanced melanoma on outcomes in a tertiary cancer center and as reported in a publicly available database.

• DOI: 10.1002/cnr2.1380
• 发表时间: 2021-08
• 期刊: Cancer reports (Hoboken, N.J.)
• 作者: Dimitrova M;Kim MJ;Osman I;Jour G
• 通讯作者: Jour G

Correction: Tumor immunogenomic signatures improve a prognostic model of melanoma survival.

• DOI: 10.1186/s12967-023-04040-7
• 发表时间: 2023-03-31
• 期刊: JOURNAL OF TRANSLATIONAL MEDICINE
• 影响因子: 7.4
• 作者: Morales, Leah;Simpson, Danny;Ferguson, Robert;Cadley, John;Esteva, Eduardo;Monson, Kelsey;Chat, Vylyny;Martinez, Carlos;Weber, Jefrey;Osman, Iman;Kirchhof, Tomas
• 通讯作者: Kirchhof, Tomas

Extended Follow-Up of Chronic Immune-Related Adverse Events Following Adjuvant Anti-PD-1 Therapy for High-Risk Resected Melanoma.

• DOI: 10.1001/jamanetworkopen.2023.27145
• 发表时间: 2023-08-01
• 期刊: JAMA NETWORK OPEN
• 影响因子: 13.8
• 作者: Goodman, Rachel S.;Lawless, Aleigha;Woodford, Rachel;Fa'ak, Faisal;Tipirneni, Asha;Patrinely, J. Randall;Yeoh, Hui Ling;Rapisuwon, Suthee;Haydon, Andrew;Osman, Iman;Mehnert, Janice M.;Long, Georgina V.;Sullivan, Ryan J.;Carlino, Matteo S.;Menzies, Alexander M.;Johnson, Douglas B.
• 通讯作者: Johnson, Douglas B.

Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915).

• DOI: 10.1200/jco.22.00533
• 发表时间: 2023-01-20
• 期刊: Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Outcomes of patients with resected stage III/IV acral or mucosal melanoma, treated with adjuvant anti-PD-1 based therapy.

接受基于抗 PD-1 辅助治疗的 III/IV 期肢端或粘膜黑色素瘤切除患者的结果。

• DOI: 10.1016/j.ejca.2024.113563
• 发表时间: 2024
• 期刊: European journal of cancer (Oxford, England : 1990)
• 作者: Jacques,SarahK;McKeown,Janet;Grover,Piyush;Johnson,DouglasB;Zaremba,Anne;Dimitriou,Florentia;Weiser,Roi;Farid,Mohamad;Namikawa,Kenjiro;Sullivan,RyanJ;Rutkowski,Piotr;Lebbe,Celeste;Hamid,Omid;Zager,JonathanS;Michielin,Olivi
• 通讯作者: Michielin,Olivi