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Cancer Therapy Evaluation Program (CTEP)
Last Updated: 04/08/16

Cancer Immunotherapy Trials Network (CITN)

The Cancer Immunotherapy Trials Network (CITN) was established in the Fall of 2010 through a U01 cooperative agreement award to the Fred Hutchinson Cancer Research Center, Dr. Mac Cheever, PI. The award funds a Central Operations and Statistical Office (COSC), with Member sites, currently numbering 30, supported by subcontracts within the COSC award. The purpose of the award was to create a consortium of the leading investigators and institutions with expertise in tumor immunology and cancer immunotherapy, to develop and implement early phase clinical trials in this field. The goals reflected an imperative to bring to the clinic those agents specifically identified and prioritized at the 2007 NCI-organized "Immunotherapy Agent Workshop" as being particularly promising for translation to the clinic but to date were unavailable for clinical trials at that time. A second component of the CITN is designed to support tumor immunology laboratories to conduct standardized immunomonitoring assays and correlative studies, using specimens obtained from the clinical trials, in order to facilitate an understanding of the biological mechanisms underpinning results from these trials. A subcontract to the laboratory of Dr. Nora Disis at the University of Washington provides the core Immune Monitoring Laboratory (IML), for the bulk of these studies, in conjunction with studies at "mini"-labs at several member institutions.

The network has activated 8 clinical trials, with 5 trials expected to open in late 2015 or early 2016. Of the 8 open trials, two have completed accrual, and follow up and evaluation of immune response data is ongoing, and the remaining 6 are actively accruing patients. Ongoing trials are two that are testing formulations of the cytokine IL-15 in various solid tumors, a trial testing the cytokine IL-7 in prostate cancer after sipuleucel-T, two trials testing the an inhibitor of the immunosuppressive agent IDO, and two trials testing the PD1/PDL1 checkpoint blockade inhibitor Pembrolizumab (one for patients with advanced Merkel cell carcinoma and one for Mycosis Fungoides). Interim results from the Merkel cell trial has revealed remarkable clinical responses in the first 24 patients who received one dose of the drug: objective clinical responses (CR or PR) were observed in 10 of 14 evaluable patients (71%). Lastly, a trial testing a Flt3 ligand in combination with PolyICLC adjuvant plus vaccine is closed to accrual and is in follow-up. The IML is actively testing specimens from all 8 open trials.