The Cancer Immunotherapy Trials Network (CITN), a multi-institutional consortium, focuses on early-phase clinical trials that test immunotherapeutic agents and modalities to treat patients with cancer. The Central Operations and Statistical Center (COSC) of the CITN will be based at the Fred Hutchinson Cancer Research Center (FHCRC). The COSC will provide leadership and organizational resources, including infrastructure, statistical support, and protocol coordination, for up to 25 member institutions and tumor immunology laboratories throughout the US. The research goals include: (1) creating and managing the CITN COSC to run a network of leading investigators and institutions to conduct early-phase clinical trials to determine the safety, toxicity, and efficacy of promising agents and strategies to prevent and treat cancer by immune mechanisms;(2) initiating at least 15 phase I or early phase II trials over the course of the funding period that investigate the basic mechanisms of immune evasion and resistance of cancers as an integral part of clinical trials;and (3) integrating a number of tumor immunology laboratories into the CITN to enable the use of specimens obtained from patients on CITN clinical trials for immunomonitoring, biomarker development and credentialing, and facilitating an understanding of the biological mechanisms that underlie the results of the clinical trials. A major strategy will be to proactively choose the """"""""best"""""""" peer-reviewed concepts from the broad immunotherapy community and use the collective experience of the CITN Steering Committee to construct """"""""ideal"""""""" protocols including use of hard-to-get prioritized immunotherapy agents. The PI and Co-Investigators combine long successful histories of multicenter clinical trial conduct, early-phase immunotherapy research, and good laboratory practice and monitoring. The CITN will model the best practices and collaborate directly with scientists and management of the FHCRC-based HIV Vaccine Trials Network, an international consortium that conducts HIV-related immunotherapeutic clinical trials.

Public Health Relevance

There is enormous potential to improve cancer therapy through the use of agents that boost patients'immune systems to fight their own disease. Few of these agents are being adequately tested in patients. This application proposes a Cancer Immunotherapy Trials Network to employ the collective expertise of top immunologists to design and conduct cancer therapy trials with the most promising of these agents.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZCA1-SRLB-9 (O1))
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Merritt, William D
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Fred Hutchinson Cancer Research Center
United States
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Margolin, Kim; Morishima, Chihiro; Velcheti, Vamsidhar et al. (2018) Phase I Trial of ALT-803, A Novel Recombinant IL15 Complex, in Patients with Advanced Solid Tumors. Clin Cancer Res 24:5552-5561
Miller, Jeffrey S; Morishima, Chihiro; McNeel, Douglas G et al. (2018) A First-in-Human Phase I Study of Subcutaneous Outpatient Recombinant Human IL15 (rhIL15) in Adults with Advanced Solid Tumors. Clin Cancer Res 24:1525-1535
Danaher, Patrick; Warren, Sarah; Dennis, Lucas et al. (2017) Gene expression markers of Tumor Infiltrating Leukocytes. J Immunother Cancer 5:18
Liao, John B; Swensen, Ron E; Ovenell, Kelsie J et al. (2017) Phase II trial of albumin-bound paclitaxel and granulocyte macrophage colony-stimulating factor as an immune modulator in recurrent platinum resistant ovarian cancer. Gynecol Oncol 144:480-485
Nghiem, Paul T; Bhatia, Shailender; Lipson, Evan J et al. (2016) PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma. N Engl J Med 374:2542-52
Miller, Natalie J; Bhatia, Shailender; Parvathaneni, Upendra et al. (2013) Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma. Curr Treat Options Oncol 14:249-63
Disis, Mary L (2011) Immunologic biomarkers as correlates of clinical response to cancer immunotherapy. Cancer Immunol Immunother 60:433-42