Comparative Oncology Trials Consortium

Division Of Basic Sciences - Nci

Investigators

Linked publications, trials & patents

Abstract

The core component of the Comparative Oncology Program (COP) is the Comparative Oncology Trials Consortium (NCI-COTC), which is an infrastructure uniting study sponsors, such as pharmaceutical and biotechnology companies, with currently 18 academic veterinary centers within North America to support multicenter clinical trials of investigational therapeutics, wherein centralized trial support and data management is provided by the NCI. This clinical trial infrastructure supports the integration of pet dogs with cancer into the development path of new cancer drugs. The COTC initiates pet animal trials in collaboration with other NCI investigators, academic institutions and/or the pharmaceutical industry. These trials are implemented through the collective caseloads of the consortium membership with COTC member institutions united through a single Memorandum of Understanding (MOU). These trials are typically small and focused on relevant biological endpoints associated with drug development. The pet animal trials are intended to answer specific questions regarding the properties of a drug and results are to be rapidly integrated into the development plans for novel therapeutic agents by the sponsor. The data generated through these studies are available to COTC members to facilitate larger investigator-initiated pet animal trials that may further complement this translational process. The COP provides leadership, oversight, and management of trials. Trial sponsors, most often pharmaceutical companies, support the clinical costs of studies conducted by the COTC. This support is paid directly to COTC centers by the sponsor through collectively defined contracts, and this process has been streamlined so as to not create a barrier to the trial. A requirement is that the scientific question related to human drug development must be explicitly and clearly stated in the protocol. Due to the unique positioning of the COP, the framework of these questions is usually guided by the COP as many outside investigators are unfamiliar with this process. Trials conducted by the COTC are designed to include clinical and biological endpoints, i.e. pharmacokinetics and pharmacodynamics, so as to optimally inform the design of early phase human trials and assist in the difficult transitions between early and later phase human trials. The process of trial initiation and scientific development is led by the COP but involves detailed and iterative discussions with the trial sponsor and COTC investigators. The first completed COTC trial was published in 2009 and the 34th trial concept is currently open for enrollment. Currently the COTC has 5 open studies: 1) COTC027: A comparison of 2 novel demethylating agents in canine solid tumors and lymphoma; 2) COTC029a: BG34-200 immunotherapy for canine cancers; 3) COTC031a: Chimeric anti-CTLA4 therapy in canine cancer; 4) COTC033a/b: Repurposing anti-viral immunity for solid tumor therapy in dogs; 5) COTC034: Amputation-only therapy in canine osteosarcoma - a natural history study with immunologic and genomic correlates. Recent publications from COTC trials highlight the value of the work, specifically in osteosarcoma and immunotherapeutic development.