John Theurer Cancer Center Launches Clinical Trial of Personalized Cancer Vaccine Using New Gene-Based Technology for High-Risk Melanoma

Researchers hope the vaccine, combined with immunotherapy, can reduce the risk of relapse in patients after melanoma surgery

John Theurer Cancer Center at Hackensack University Medical Center is the only site in New Jersey and one of just 17 in the country participating in a multicenter international Phase II study of an innovative personalized cancer vaccine being evaluated in combination with pembrolizumab immunotherapy in patients with melanoma that has been surgically removed but has a high risk of coming back. The hope is that the vaccine can prime a patient's immune system to be more responsive to immunotherapy and reduce the risk of cancer recurrence. Utilizing a novel and potentially revolutionary gene-based technology, the vaccine is created by comparing the patient’s normal cell DNA sequence to that of their tumor and identifying tumor specific changes to the DNA. Once identified, the patient-specific, tumor-specific changes are turned into a messenger RNA construct to be used as a vaccine.

Pembrolizumab belongs to a class of drugs called "checkpoint inhibitors," which have transformed the treatment of melanoma. It works by blocking a protein called PD-1 which normally shuts down the immune response. Cancer cells use PD-1 to hide from the immune system. Inhibiting PD-1 enables the immune system to find and kill cancer cells.

"Pembrolizumab and other checkpoint inhibitors have been shown to reduce disease recurrence among patients with high-risk melanoma that was surgically removed. However, in many patients, the cancer eventually comes back," explained Andrew L. Pecora, M.D., FACP, CPE, a nationally recognized hematologist/oncologist at John Theurer Cancer Center and associate dean, Technology and Innovation, Hackensack Meridian School of Medicine at Seton Hall University, who is a principle investigator (PI) of the study. "Reducing the rate of relapse would address a significant unmet medical need for these patients."

The study, "A Phase II Randomized Study of Adjuvant Immunotherapy with the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab versus Pembrolizumab Alone after Complete

Resection of High-Risk Melanoma," is assessing a vaccine made by ModernaTX, Inc. called mRNA-4157. A personalized vaccine is made and given back to the patient to trigger the immune response.

John Theurer Cancer Center was also a study site for the Phase I clinical trial of the vaccine, which was assessed alone and in combination with pembrolizumab in patients with a variety of solid tumors. The results, which were presented at the 2019 Annual Meeting of the American Society of Clinical Oncology, were promising — showing that mRMA-4157 was well tolerated, provoked an immune response, and resulted in clinical responses when given with pembrolizumab.

"Immunotherapy is revolutionizing cancer care, but challenges remain. This is a very exciting customized anticancer vaccine using a novel technology," noted Martin E. Gutierrez, M.D., director of Drug Discovery and the Phase I Unit, chief of Thoracic Oncology at John Theurer Cancer Center, and a PI of the Phase I study. "We are encouraged by the Phase I findings and are hopeful that the Phase II study results will show a similar positive outcome for these patients."

"Participation in groundbreaking studies such as these demonstrates John Theurer Cancer Center's leadership in clinical research," added Andre Goy, M.D., MS, chair and executive director of John Theurer Cancer Center. "We are committed to offering our patients the latest medical advances and furthering progress in cancer care through clinical investigation."

“Hackensack University Medical Center is delivering cutting-edge cancer treatments options for our patients,” said Ihor Sawczuk, M.D., FACS, president, Northern Region, chief research officer, Hackensack Meridian Health. “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.”

“Hackensack University Medical Center is advancing research and innovation to discover new treatment options for our patients,” said Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center and executive vice president of Population Health, Hackensack Meridian Health. “We look forward to seeing how this innovative vaccine and advances in immunotherapy will help us expand treatment options for patients with melanoma.”