Chapel Hill-based University of North Carolina Lineberger Comprehensive Cancer Center has been awarded up to $28 million to develop an adaptive clinical trial targeting metastatic breast cancer.
The trial is part of the Advanced Research Projects Agency for Health’s Advanced Analysis for Precision Cancer Therapy program, also called ADAPT. Other ADAPT awardees and their trial focuses can be found here.
UNC Lineberger and 14 other institutions will use real-time biomarker data collected through clinical trial research to adapt treatment plans as tumor biology changes as part of the Translational Breast Cancer Research Consortium Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies, known as EVOLVE.
Lisa Carey, MD, the L. Richardson and Marilyn Jacobs Preyer Distinguished Professor for Breast Cancer Research at UNC School of Medicine and the deputy director of clinical sciences at UNC Lineberger, is the study’s lead investigator.
Dr. Carey spoke to Becker’s about how the EVOLVE trial differs from other clinical trials and how the trial results will be scaled.
Editor’s note: Responses have been lightly edited for clarity and length.
Question: Can you briefly describe the study model and how it will evolve as more insights are gained?
Dr. Lisa Carey: TBCRC EVOLVE is an adaptive trial, meaning that within the clinical trial, new sub-trials will be started and stopped quickly on the basis of early “looks” on effectiveness of a new drug or regimen based on biologic insights and the trial results that are calculated in real time.
This kind of trial is complex and is a bit of a high-wire act because we are training biomarker models to predict responsiveness at the same time as we are testing promising drugs or regimens.
Q: How might the trial results inform how precision medicine care models are/will be scaled?
LC: The EVOLVE team is focused on the breast cancer parent trial and all its sub-trials. There are two other clinical trial teams, one in colon cancer led by MD Anderson investigators, the other in lung cancer led by City of Hope investigators.
In addition, there are several biomarker “laboratories,” which are largely leaders in machine learning techniques that can incorporate genetic, clinical, and radiographic data that we will provide them from the clinical trials.
In this way, we will build the infrastructure for predictive models to allow us to tailor therapy; at the same time, we can test novel approaches that will be designed to circumvent resistance patterns.
Q: What role do you see public-private-academic partnerships playing in advancing cancer care?
LC: Cancer care and the improvements in mortality from many, although not all, cancers is already due to remarkable engagement and intersection of patients participating in trials, academic centers identifying clinical challenges — helping prioritize approaches and performing basic and translational science to identify promising treatment directions — and private or industry partners who can develop drugs, devices, and assays that help our patients.
The beauty of this ARPA-H initiative is that it is even more focused on the place where science meets clinical care in three very common and lethal metastatic cancers — breast, colon and lung.
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