SYNERGY-AI: Session Information

Authors:

Selin Kurnaz, Arturo Loaiza-Bonilla, Jason Lawrence Freedman, Belisario Augusto Arango, Kristin Johnston, Paula Andrea Bonilla-Reyes, Cagatay M Culcuoglu, SYNERGY-AI Precision Oncology Group; Massive Bio, Inc., New York, NY; Cancer Treatment Centers of America, Philadelphia, PA; Children’s Hospital of Philadelphia, Philadelphia, PA; War Memorial Hospital, Sault Ste. Marie, MI; Pontificia Universidad Javeriana, Bogota, Colombia

Background:

Precision oncology encompasses the implementation of high level of evidence disease-specific and biomarker-driven diagnostic and treatment recommendations for optimized cancer care. Artificial Intelligence (AI), telemedicine and value-based care may optimize clinical trial enrollment (CTE) and overall cost-benefit. This ongoing, international registry for cancer pts evaluates the feasibility and clinical utility of an AI-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate CTE, as well as the financial impact, and potential outcomes of the intervention.

Methods:

The SYNERGY-AI Registry is an international prospective, observational cohort study of eligible adult and pediatric pts with advanced solid and hematological malignancies, for whom the decision to consider CTE has already been made by their primary providers (PP). Using a proprietary application programming interface (API) linked to existing electronic health records (EHR) platforms, individual clinical data is extracted, analyzed and matched to a parametric database of existing institutional and non-institutional CTs. Machine learning algorithms allow for dynamic matching based on CT allocation and availability for optimized matching. Patients voluntarily enroll into registry, which is non-interventional with no protocol-mandated tests/procedures—all treatment decisions are made at the discretion of PP in consultation with their pts, based on the AI CT matching report, and VTB support. CTE will be assessed on variables including biomarkers, barriers to enrollment. Study duration anticipated as ~36 mo (~24-mo enrollment followed by 12 mo of data collection, to occur every 3 mo). The primary analysis will be performed 12 mo after last pt enrolled. The impact time to initiation of CTE on PFS and OS will be estimated by Kaplan-Meier and Cox multivariable survival analysis. Enrollment is ongoing, with a target of ≥ 1500 patients. Key inclusion criteria: Pts with solid and hematological malignancies; cancer-related biomarkers. Key exclusion criteria: ECOG PS > 2; abnormal organ function; hospice enrollment Clinical trial information: NCT03452774