LOS ANGELES (Feb. 18, 2014) – The Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute has opened a novel Phase III, vaccine-based clinical trial aimed at providing kidney cancer patients long-term control of their disease.
Survival outcomes for patients with renal cell carcinoma, the most common form of kidney cancer, have improved significantly over the past decade due to research advances in personalized or "targeted" therapies designed to target an individual's genetic makeup. To expedite these benefits, investigators are now looking to couple targeted therapies with vaccine-based approaches, which use a patient's own immune system to fight disease and may have the potential to improve survival outcomes and overall quality of life.
In "Ask the Author: Drug Evaluation," an article published in the journal Immunotherapy, Robert Figlin, MD, deputy director of the Samuel Oschin Comprehensive Cancer Institute and global principal investigator of the Phase III clinical trial, explains that combining targeted therapies with a vaccine-based approach may revolutionize the treatment of renal cell carcinoma through the next decade.
"Translational research efforts in advanced renal cell carcinoma are providing the best hope and the strongest outcomes for patients," said Figlin, the Steven Spielberg Family Chair in Hematology Oncology. "With innovative thinking and treatment approaches, and learning from past progress, we are paving the way for promising research advancements and improved patient care."
To further test the outcomes of combining a vaccine-based approach with targeted therapies, Cedars-Sinai is enrolling patients in the clinical trial using an investigational vaccine known as AGS-003. This trial acts in combination with the targeted therapy Sunitinib to maximize an immune response in patients, with a goal of adding little to no toxicity.
"This clinical trial asks one of the most important questions facing the field of kidney cancer at this time: Is there synergy between immunotherapy and targeted agents?" said Edwin Posadas, MD, co-investigator of the clinical trial, medical director of the Urologic Oncology Program at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute and associate professor in the Department of Medicine. "This study could be the first of many to truly redefine the approach investigators take to treat kidney cancer in the clinic."
The AGS-003 clinical trial, or ADAPT trial, is the first-of-its-kind international study and is available in more than100 centers. The goal of this personalized immunotherapy is to allow a patient's own tumor and cells to boost their fight against their particular cancer.
Patients interested in kidney cancer or other clinical trials at Cedars-Sinai may visit http://cancertrialinfo.csmc.edu or contact Jaime Richardson, RN, clinical trial navigator at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute, at 310-423-2133 or cancer.trial.info@cshs.org.
Phase III ADAPT Trial: An International Phase III Randomized Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma.
Citation: Immunotherapy. 2013 December: A novel personalized vaccine approach in combination with targeted therapy in advanced renal cell carcinoma.
COI Disclosure: Robert Figlin, MD, receives consulting fees from Argos Therapeutics, the sponsor of the clinical trial.