John H. Stewart IV, M.D., associate professor of surgery and associate dean for clinical research and innovation, is the principal investigator for the Wake Forest Baptist study site. The Phase III clinical trial known as ADAPT, is a randomized, multicenter study that plans to enroll 450 patients overall, under an approved Special Protocol Assessment by the U.S. Food and Drug Administration. Stewart said he hopes to enroll at least 10 patients per year from Wake Forest Baptist.
The study will evaluate AGS-003, an investigational, personalized immunotherapy designed to stimulate a tumor-specific T-cell response. AGS-003 will be evaluated in combination with standard surgery followed by targeted drug therapy to determine its potential to extend overall survival in newly diagnosed, metastatic renal cell carcinoma (mRCC) patients. Secondary endpoints of the study include progression-free survival, safety, overall response and immune response.
“This trial is a great example of personalized medicine,” Stewart said, “and really highlights multidisciplinary efforts in taking care of patients with advanced cancers.”
In this instance, he said, a patient with metastatic renal cell cancer is treated by the medical oncologist, the kidney is removed by the urologist, a vaccine is made from the patient’s tumor cells by a basic scientist and then the immunotherapy is administered by the team in surgical oncology. “It is exciting to see how personalized medicine can extend across so many disciplines,” Stewart said. “It’s important for all clinical stakeholders to work together to bring exciting new therapies to our patients.”
To date, more than 50 sites are participating and more than 30 subjects have been enrolled in North America. The study is expected to expand to more than 120 global sites by early fall, according to Argos Therapeutics Inc., a biopharmaceutical company that is utilizing its Arcelis™ Technology Platform, an active immunotherapy technology that captures all antigens, including mutated and variant antigens that are specific to each patient’s disease. It has been shown to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that are associated with toxicity.
Information about this clinical trial and others can be found at www.wakehealth.edu/BeInvolved.