Coordinating Center for Canine Immunotherapy Trials and Correlative Studies

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The primary mission of goal of the Pre-medical Cancer Immunotherapy Network for Canine Trials (PRECINCT) is to facilitate the performance of immunotherapy clinical trials in dogs with cancer and to expedite the identification of immunological correlates of successful therapeutic responses. The PRECINCT will achieve these goal by supporting a highly coordinated clinical trials network of participating U01 sites. As a coordinating center, the PRECINCT will work in consultation with U01 investigators, the Steering Committee, representatives from the Comparative Oncology Program (COP) at NCI and an External Advisory Committee to provide expert services in project management and research technology, data management, biostatistical support and immunological monitoring. Specifically, we will establish a PRECINCT Data Coordinating Center to provide comprehensive project oversight, supervise all project management and regulatory compliance activities, and coordinate site management for all aspects of single and large multi-site projects. Through the PRECINCT, U01 investigators will have ready access to research services and standardized protocols that will facilitate the performance of clinical research across the PRECINCT. We will establish a PRECINCT Data Management System to collect, store and share all clinical and correlative data amongst the U01 sites and with the COP directors and Steering Committee. We will develop the infrastructure necessary to achieve an efficient, highly functioning coordinated network and develop standard operating procedures (SOPs) that can be applied across all PRECINCT-associated U01 projects to ensure high quality, repeatable data sets. We will provide biostatistical support for study design and data analysis to ensure that immunotherapy clinical trials performed within the network are strategically designed and appropriately powered to achieve meaningful clinical and laboratory data results in the most expedite way. The renowned expertise of the University of Pennsylvania in both human and canine clinical trials will foster rapid translation of state-of-the art methods for human clinical study design and analysis to canine clinical trials and results from canine trials can rapidly inform human clinical trials, thus optimizing results for both species. Finally, the University of Pennsylvania is a leader in cancer immunotherapy and is also home to world renowned experts in immune reagent development and immunological monitoring. We will leverage this expertise to both accelerate the mission of the U24 and extend it by providing support for immunologic reagent development for use in correlative studies and biomarker identification. In concert with U01 investigators, the COP and the Steering Committee, we will design, generate and validate several multiparametric, multicolor flow panels and SOPs for their use across the U01 sites. Successful immunologic monitoring will allow canine cancer patients to be streamlined to single or combination therapies most likely to be effective and will provide essential insight for future translational application to human cancer patients.