ABSTRACT: This application is being submitted to request the addition of University of Kansas Cancer Center (KUCC) as an Affiliated Organization (AO) to our NCI Experimental Therapeutics-Clinical Trials Network (ETCTN) UM1 Lead Academic Organization. KUCC, previously a “Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP)” site will enhance access of trials in the Early Therapeutics Clinical Trials Network for underserved populations (USP) in Kansas and enhance USP to our ETCTN consortium. The purpose of the ETCTN is to develop new therapeutic options while also defining better approaches for the development of novel anticancer agents that capitalize on the ability to characterize tumors molecularly. As a result, a unique network such as the ETCTN, consisting of multiple scientifically-driven sites and investigators with a vast array of expertise, is needed. In 2020, we were awarded a UM1 grant (2UM1CA186689-06). In July 2022, the NCI Cancer Therapy Evaluation Program (CTEP) recommended that we submit this administrative supplement to offset some of the costs of absorbing KUCC as an additional AO to provide continuity for CATCH- UP sites participating on ETCTN active trials (those with patients on treatment and in follow-up) as well as recruit additional patients from USP to increase access of novel therapeutic agents to these respective populations. Our original partnerships included Vanderbilt-Ingram, University of California San Diego, University of Oklahoma Stephenson Cancer Center and the Yale Cancer Center (VICtOrY). We subsequently added Columbia University, Washington University in St. Louis, and the University of Florida. We now plan to add KUCC to our consortium to form VICtOrY-CWFK. Our team aims to 1) leverage novel scientific discoveries for translation into early phase trials, using the CTEP pharmacopeia, in rare cancers, common cancers, and uncommon variants of common cancers; 2) incorporate serum, tissue and imaging biomarkers to better understand the effects of novel agents either alone or in combination; 3) train early career investigators to be knowledgeable and proficient in conducting early phase clinical trials by providing clinical research leadership opportunities and mentoring; and 4) include as a component of our early phase clinical trial recruitment, no less than 30% USP populations including 20% consisting of traditional ethnic/racial minority patients with recruitment of at least 50% USP recruited at KUCC. The members of our team, along with the proposed additional site, have a unique set of complementary expertise and a similar philosophy regarding collaborative research and mentorship of the next generation of cancer investigators. Together, VICtOrY-CWFK is committed to utilizing our areas of expertise, integrating the science at our institutions, and maximizing our collaborative relationships to conduct cutting-edge early phase trials within the ETCTN with the ultimate mission of improving outcomes for cancer patients.

This application is being submitted to request the addition of an Affiliated Organization (AO) to an ETCTN UM1 Lead Academic Organization (Yale University). Addition of the AO, the University of Kansas Cancer Center, will provide continuity for a productive site still conducting active ETCTN trials but which was not included in a funded ETCTN UM1 Type 2 award. Their inclusion enhances the ability of our consortium to perform comprehensive conduct of early clinical trials, conduct more selective and sophisticated clinical and translational investigational strategies, and will increase accrual of underserved populations to trials conducted under our ETCTN UM1.