The John Theurer Cancer Center, Hackensack University Medical Center reports they are the only clinical investigational site in New Jersey—and the only one of just 17 sites around America—participating in a multicenter international Phase II study on an innovative personalized cancer vaccine. Dr. Andrew Pecora will assess the efficacy of Moderna’s mRNA-4157 in combination with the checkpoint inhibitor pembrolizumab.
Although checkpoint inhibitors such as pembrolizumab have transformed the care of melanoma, many patients are at risk that the cancer comes back and hence a new vaccine needs to be considered along with the checkpoint inhibitor.
The vaccine is being evaluated in combination with pembrolizumab immunotherapy in patients with melanoma that has been surgically removed but has a high risk of return. The sponsor and sites hope that the vaccine can ready a patient’s immune system to be more responsible to immunotherapy and, hence, lower the risk of cancer recurrence.
The study, “A Phase II Randomized Study of Adjuvant Immunotherpay with the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab versus Pembrolizumab Alone after Complete Resection of High-Risk Melanoma” assesses a vaccine made by ModernaTX Inc. called mRNA-4157. TrialSite News has profiled Moderna. In the study, a personalized vaccine is developed and reinfused back into the patient to trigger the immune response.
Hackensack University Medical Center’s John Theurer Cancer Center was involved with the Phase I clinical trial of this vaccine developed by sponsor Moderna. The vaccine was assessed alone and in combination with pembrolizumab in patients with a variety of solid tumors. As reported in New Jersey Business Magazine, the Phase I promising results were presented at the 2019 Annual meeting of the American Society of Clinical Oncology. The results revealed that mRMA-4157 was well tolerated, stimulated an immune response and resulted in clinical responses when administered with pembrolizumab.
The study is basing the research on a novel, potentially revolutionary gene-based technology where the vaccine is created by comparing the patient’s normal cell DNA sequence to that of their tumor and in the process identify tumor-specific changes to the DNA. Once this has been identified, the patient-specific tumor-specific modifications are transformed into a messenger RNA construct to be utilized for the vaccine.
The vaccine will be used in combination with pembrolizumab, a checkpoint inhibitor that has transformed the treatment of melanoma. This class of therapy blocks PD-1 (a protein) which normally turns off the immune response. Cancer cells evolve to exploit PD-1, hiding from the immune system—hence, as part of this study, the sites will inhibit PD-1 enabling the immune system to seek out and destroy the cancer cells.
The Principal Investigator
Andrew L. Pecora, MD, FACP, CPE and a nationally recognized hematologist/oncologist at John Theurer Cancer Center, as well as associate dean, Technology and Innovation, Hackensack Meridian School of Medicine, Seton Hall University will lead the charge in New Jersey as the state’s only principal investigator on this study.
Hackensack University Medical Center
Hackensack University Medical Center (HUMC) continues to serve as a cutting-edge clinical investigational site in New Jersey. The 770-bed non-profit, research and teaching hospital is just seven miles west of New York City. The center offers tertiary and healthcare needs for Northern New Jersey and the New York City metropolitan area. HUMC is New Jersey’s second largest provider of inpatient and outpatient services according to some sources.
Founded in 1888 at what at the time was Bergen County’s first hospital, it now is Bergen County’s largest employer with around 9,000 employees with an annual budget of over $1 billion; 1,400 physicians and dentists are employed there.
The John Theurer Cancer Center is participating in advanced gene-therapy clinical trial programs. According to Ihor Sawczuk, MD, FACS, president, Northern Region, chief research officer, Hackensack Meridian Health, “Hackensack Medical Center is delivering cutting-edge cancer treatment options for our patients,” and continued, “By utilizing gene-based technology, we are offering patients hope with a personalized cancer vaccine that can boost immune responses and reduce the risk of relapse for melanoma patients.”
Mark D. Sparta, FACHE, president and chief hospital executive and executive vice president of Population Health, Hackensack Meridian Health noted, “Hackensack University Medical Center is advancing research and innovation to discover new treatment options for our patients.”
Andrew L. Pecora, MD, FACP, CPE
Call to Action: This research showcases the abilities of the John Theurer Cancer Center to take on complex, advanced gene therapy trials such as the type associated with Moderna’s mRNA-4157.