Cancer Immunotherapy Trials Network Central Operations and Statistical Center

癌症免疫治疗试验网络中央运营和统计中心

• 批准号: 9568709
• 负责人: Martin Alexander Cheever
• 金额: $ 486.42万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-22 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9568709
• 关键词: Adult; Anti-CD40; Award; Biological Markers; Biopsy; Cancer Center; Clinical Trials; Conduct Clinical Trials; Credentialing; Dendritic Cells; Educational workshop; FLT3 ligand; Failure; Future; Goals; Growth Factor; Immune response; Immunologic Monitoring; Immunomodulators; Immunotherapeutic agent; Industry; Institution; Interleukin-15; Interleukin-2; Interleukin-7; Knowledge; Leadership; Link; Malignant Childhood Neoplasm; Malignant Neoplasms; Myelogenous; Myeloid-derived suppressor cells; Natural Killer Cells; North America; Orphan; PD-1 inhibitors; Patients; Pharmaceutical Preparations; Phase; Research Infrastructure; Sea; Specimen; T-Lymphocyte; Testing; Therapeutic; Universities; anti-PD-L1; cancer immunotherapy; cancer therapy; clinical practice; immunotherapy trials; improved; innovation; investigator-initiated trial; macrophage; member; monocyte; oncology; operation; pediatric patients; statistical center; success; trial design

Project Summary The Cancer Immunotherapy Trials Network (CITN) came about from discussions at the 2007 NCI Immunotherapy Agent Workshop, in which high-priority agents were identified that showed the potential to benefit patients with cancer—but that were not yet broadly available for investigator-initiated trials (IITs). Since 2007, a sea change has occurred in the field of cancer immunotherapy, resulting from the success of anti-PD1 and anti-PD-L1. However, most of the priority agents identified in the NCI Workshop are still not broadly available for academic IITs. Since the original award in 2011, the CITN focused on testing these high-priority agents, including 5 of the top 8 ranked agents that hit targets critical for optimal immune responses. CITN trials are among the few academic IITs of these agents, and each trial has defined biologic and therapeutic principles. Two trials have led to changes in clinical practice. The abbreviated Specific Aims for the CITN are as follows: Aim 1: (a) to continue to conduct innovative early phase multicenter immunotherapy trials for adult cancers using high-priority immunomodulatory agents; (b) to form a Pediatric CITN (PedCITN) to conduct innovative early phase multicenter immunotherapy trials for pediatric cancers using high-priority immunomodulatory agents; (c) to provide leadership, infrastructure, and statistical support for the conduct of these clinical trials; (d) to continue to access high-priority agents central to immune responses and not broadly available for IITs Aim 2: to coordinate studies with Cancer Immune Monitoring and Analysis Center (CIMAC) and other labs for specimen analysis (immune monitoring, biomarker credentialing) of adult and pediatric patients on CITN trials Scientific Goals of the CITN 1. Continue trials with T cell and natural killer cell activator and growth factor IL-15, homeostatic T cell growth factor IL-7, dendritic cell activator anti-CD40, dendritic cell growth factor Flt3L, and IDO inhibitor ± anti-PD1 2. Continue trials with anti-PD1 for orphan and ultra-orphan indications, including pediatric cancers 3. Conduct biopsy-intense trials to identify actionable causes of anti-PD1 failure and linked to therapeutic administration of potential rescue agents 4. Conduct trials to assess therapies that eliminate or activate the myeloid, monocytes/macrophage, and/or myeloid-derived suppressor cells that reside within most cancers 5. Conduct multicenter Phase I and early Phase II immunotherapy trials for pediatric patients with cancer The results will inform future trial designs and improve the understanding of these high-priority agents. CITN trials are designed to identify paths to regulatory approval and will likely change standard practice or spur confirmatory pivotal trials by NCI cooperative groups and industry for adult and pediatric cancers.

项目摘要 癌症免疫疗法试验网络（CITN）来自2007年NCI的讨论 免疫疗法剂研讨会，其中确定了高优先级药物，显示出可能的潜力 有益于癌症患者，但尚未广泛用于研究人员发起的试验（IIT）。自从 2007年，由于抗PD1的成功，癌症免疫疗法领域发生了变化 和抗PD-L1。但是，在NCI研讨会中确定的大多数优先级代理人仍然不是广泛的 可用于学术IIT。 自2011年最初的奖项以来，CITN专注于测试这些高优先级代理商，其中包括最高的5个 击中击中目标的8个排名的药物对于最佳免疫反应至关重要。 CITN试验是为数不多的学术之一 这些药物的IIT，每个试验都定义了生物学和治疗原理。两次试验导致 临床实践的变化。 CITN的缩写特定目标如下： 目标1：（a）继续为成人癌症进行创新的早期多中心免疫疗法试验 使用高优先级免疫调节剂； （b）形成小儿CITN（PEDCITN）进行创新 使用高优先级免疫调节的小儿癌症的早期多中心免疫疗法试验 代理人； （c）为这些临床试验的进行提供领导，基础设施和统计支持； （d）继续访问免疫反应中心的高优先级代理，而不是广泛的IIT 目标2：与癌症免疫监测和分析中心（CIMAC）和其他实验室协调研究 成人和小儿患者的标本分析（免疫监测，生物标志物证书）在CITN试验中 CITN的科学目标 1。继续使用T细胞和天然杀伤细胞活化剂和生长因子IL-15，稳态T细胞生长进行试验 因子IL-7，树突状细胞活化剂抗CD40，树突状细胞生长因子FLT3L和IDO抑制剂±抗PD1 2。继续使用抗PD1的孤儿和超孔迹象进行试验，包括儿科取消器 3。进行活检强化试验，以识别抗PD1失败的可行原因，并与治疗有关 潜在救援人员的管理 4。进行试验以评估消除或激活髓样，单核细胞/巨噬细胞和/或 大多数癌症中的髓样衍生的抑制细胞 5。为儿科患者进行多中心I期和早期II期免疫疗法试验 结果将为未来的试验设计提供信息，并提高对这些高优先级代理的理解。 CITN 试验旨在确定监管批准的途径，可能会改变标准惯例或刺激 NCI合作团体和行业的成人和小儿取消的确认关键试验。