Advanced Clinical Trials and Translational Sciences

Mayo Clinic Rochester, Rochester MN

Investigators

Linked publications & trials

Abstract

ADVANCED CLINICAL TRIALS AND TRANSLATIONAL SCIENCES (ACTS): ABSTRACT The Advanced Clinical Trials and Translational Sciences Program (ACTS) fosters team-science approaches to drive bi-directional translational science that informs development of innovative, practice-changing clinical trials responsive to the needs of cancer patients in our catchment areas and from across the nation. The Specific Aims are to: 1) improve oncologic outcomes via practice-changing clinical trials; 2) drive paradigm-shifting cancer care discoveries via bi-directional translational science; and 3) integrate innovative cancer care delivery paradigms and therapeutic strategies and clinical trials. With a large membership across the three Mayo Clinic Comprehensive Cancer Center (MCCCC) sites, work within the program focused on specific cancer types is accomplished through Translational Science Teams (TSTs). The TSTs are populated with members from all six Research Programs who work closely with the Disease Groups to integrate bi-directional translational science within the MCCCC portfolio of clinical trials. ACTS members collaborate closely with Community Outreach and Engagement (COE) and actively engage community members through education efforts and seek community input to ensure that research aligns with community needs. Major practice-changing and paradigm-shifting scientific achievements led by ACTS members include: 1) FDA approval for dual HER2-blockade in HER2-amplified colorectal cancer (NCT03043313); 2) practice-defining trials in multiple myeloma (NCT05561387, NCT01169337, NCT01863550); 3) discovery of the immune landscape in triple negative breast cancer which determines outcome; 4) development of dramatically shorter radiation schedules for multiple cancers; 5) a trial testing delivery of subcutaneous immunotherapy (nivolumab) in patient homes (NCT06265285); and 6) a trial testing home-based chemotherapy to improve outcomes in men with prostate cancer (NCT07073794). ACTS has 121 members (86 MCR, 17 MCA, 18 MCF) from 20 departments who hold $10.7M in annual direct peer-reviewed funding ($6.4M from NCI) and $38.0M in annual non-peer reviewed industry and philanthropic funding. Notable current NIH programmatic funding includes four disease-focused NCI SPOREs, a U19, two U54s and top leadership roles within the NCI NCTN Alliance for Clinical Trials in Oncology. In this 5-year reporting period, program members have published 3683 peer-reviewed publications: 31% intra-programmatic, 38% inter-programmatic, 47% collaborative with other Centers, and 31% with impact factor ≥10. ACTS members lead a robust portfolio of investigator-initiated, NCTN, and industry trials with robust clinical trial activity; 2461 patients were accrued to ACTS interventional treatment trials from 2019-2023. Beyond clinical trials, ACTS worked closely with the MCCCC Office of Cancer Individualized Precision Medicine to develop the EXACT Sciences Interception program that offers clinical grade somatic/germline exome sequencing and transcriptome analyses for new cancer patients. Our vision is to integrate these genomic data with other digital and clinical data to provide a real-time dashboard for each patient’s cancer journey and to identify tailored research interventions.