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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

基本信息

批准号：
10688632
负责人：
NANCY ELLEN DAVIDSON
金额：
$ 60万
依托单位：
FRED HUTCHINSON CANCER CENTER
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-22 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10688632
关键词：
Adult Anti-CD40 Award Biological Markers Biological Response Modifier Therapy Biopsy Cancer Center Clinical Trials Conduct Clinical Trials Credentialing Dendritic Cells Educational workshop FLT3 ligand Failure Future Goals Growth Factor IL7 gene Immune response Immunologic Monitoring Immunomodulators Immunotherapeutic agent Industry Infrastructure Institution Interleukin-15 Interleukin-2 Knowledge Leadership Link Malignant Childhood Neoplasm Malignant Neoplasms Myelogenous Myeloid-derived suppressor cells Natural Killer Cells North America Oncology Orphan PD-1 inhibitors Patients Pharmaceutical Preparations Phase Sea Specimen T-Lymphocyte Testing Therapeutic Universities anti-PD-1 anti-PD-L1 cancer immunotherapy cancer therapy clinical practice immunotherapy trials improved innovation investigator-initiated trial macrophage member monocyte operation pediatric patients statistical center success trial design

项目摘要

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.

项目总结

项目成果

期刊论文数量（11）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

PD-1 and TIGIT coexpression identifies a circulating CD8 T cell subset predictive of response to anti-PD-1 therapy.

DOI：
10.1136/jitc-2020-001631
发表时间：
2020-11
期刊：
Journal for immunotherapy of cancer
影响因子：
10.9
作者：
Simon S;Voillet V;Vignard V;Wu Z;Dabrowski C;Jouand N;Beauvais T;Khammari A;Braudeau C;Josien R;Adotevi O;Laheurte C;Aubin F;Nardin C;Rulli S;Gottardo R;Ramchurren N;Cheever M;Fling SP;Church CD;Nghiem P;Dreno B;Riddell SR;Labarriere N
通讯作者：
Labarriere N

A translational program that suppresses metabolism to shield the genome.

DOI：
10.1038/s41467-020-19602-2
发表时间：
2020-11-13
期刊：
Nature communications
影响因子：
16.6
作者：
Balukoff NC;Ho JJD;Theodoridis PR;Wang M;Bokros M;Llanio LM;Krieger JR;Schatz JH;Lee S
通讯作者：
Lee S

Use of pembrolizumab with or without pomalidomide in HIV-associated non-Hodgkin's lymphoma.

DOI：
10.1136/jitc-2020-002097
发表时间：
2021-03
期刊：
Journal for immunotherapy of cancer
影响因子：
10.9
作者：
Lurain K;Ramaswami R;Mangusan R;Widell A;Ekwede I;George J;Ambinder R;Cheever M;Gulley JL;Goncalves PH;Wang HW;Uldrick TS;Yarchoan R
通讯作者：
Yarchoan R

Pembrolizumab induces HIV latency reversal in people living with HIV and cancer on antiretroviral therapy.