Massey opens clinical trial testing a new immunotherapy for metastatic melanoma
VCU Massey Cancer Center is one of 17 global sites (and one of 14 in the U.S.) participating in a phase 2 clinical trial to evaluate the effectiveness and safety of an adoptive cell-transfer therapy to treat patients with metastatic melanoma. The trial, which uses the patient’s own tumor to grow immune cells designed to attack cancerous cells in the body, represents the first cell-based immunotherapy performed at VCU Massey Cancer Center.
Metastatic melanoma is a skin cancer that has spread to other organs or tissue far away from the original tumor. The clinical trial’s investigational product, called LN-144, is made of white blood cells called tumor infiltrating lymphocytes (TIL) that have left the blood stream and migrated into the tumor. Harvesting these specialized anti-cancer cells requires surgical removal of a portion of the patient’s tumor, which is then sent to a facility to isolate and grow billions of TIL cells that will be later infused back into the patient.
Growing the TIL cells from a resected tumor can take to 2 to 4 weeks. Once cell growth is confirmed to be successful, patients are admitted for a week of chemotherapy to temporarily rid them of their own immune cells to make room for the TIL cells. Following the one-time infusion with LN-144, patients will receive interleukin-2 (IL-2) therapy for a maximum of 6 doses over 2-3 days. IL-2 is a naturally-occurring immune stimulant; here it is used to further boost the infused TIL cells.
“Immunotherapy, utilizing one’s own immune system to attack cancer cells, has revolutionized cancer therapy,” said Giao Q. Phan, M.D., F.A.C.S., a surgical oncologist and member of Massey’s Developmental Therapeutics research program. “This type of cell-based immunotherapy is the essence of personalized medicine. Each treatment is developed for each patient.
“We are excited to be working alongside other leading cancer research institutions to bring this treatment to patients at Massey. Most importantly, once the TIL cells are engineered to kill the tumor, they are potentially active all the time, even when the patient is not actively receiving therapy.”
The clinical trial, sponsored by Iovance Biotherapeutics, is open to approximately 60 patients with unresectable metastatic melanoma (surgery is not an option) between the ages 18-70 who have gone through standard first-line therapy and are still experiencing cancer growth. Portions of tumor tissue collected for LN-144 generation will be used to look at various cells that make up the tumor, and blood samples will examine how the treatment is affecting the patient’s cells. Additional DNA testing may also be performed.
In addition to studying the efficacy of LN-144 TIL, the clinical trial will also evaluate the persistence of LN-144 in anti-tumor immunity, patient outcomes and side effects.
To enroll or receive more information about this study, please contact Giao Phan, M.D., F.A.C.S., at (804) 828-9324.