Newly diagnosed patients with kidney cancer that has spread beyond the kidney may be eligible to participate in a phase three clinical trial at Upstate to determine if investigational immunotherapy AGS-003 will improve survival when combined with standard treatment. Upstate is one of the first sites in the country to offer the clinical trial to patients. AGS-003 is the first fully personalized cancer immunotherapy being developed for the treatment of metastatic renal cell carcinoma. The immunotherapy is designed to trigger the body‘s natural immune response to help recognize and kill cancer cells.

Dr. Gennady Bratslavsky, MD, professor and chair of the Department of Urology, is principal investigator of the study at Upstate, one of 120 sites in the world to participate. The study is sponsored by Argos Therapeutics and  is expected to enroll 450 patients.

“Despite recent advances in the area of targeted drug therapies, expected survival is still limited for most patients,” Bratslavsky said. “Previous AGS-003 studies for this type of kidney cancer have shown encouraging results and could provide an improved treatment option and new hope for patients.”

To create AGS-003, ribonucleic acid or the tumor‘s “code” is isolated from a small tumor sample obtained from a standard tumor removal surgery. The patient‘s specialized white blood cells are taken during a blood donation procedure a few weeks later. The tumor RNA is used to “program” the specialized white blood cells with all of the signals necessary to trigger an immune response against the patient‘s specific cancer. These “programmed” specialized white blood cells are then formulated into a ready-to-use injection. In three previous clinical studies, AGS-003 has been well tolerated by patients.

“Surgical removal of the tumor and sometimes the entire kidney remains the mainstay of initial treatment for newly diagnosed patients,” said Bratslavsky. “The tumor sample used to develop AGS-003 is easily obtained during this routine procedure and is, in fact, critical to personalizing the therapy so that the patient‘s immune system can recognize and target their specific cancer cells.”

To be considered for the ADAPT study patients must be:

• 18 or older and newly diagnosed with clear cell metastatic renal cell carcinoma.

• Patients must be good candidates for standard tumor removal surgery and for treatment with standard targeted drug therapy, starting with sunitinib (Sutent®).

Contact Upstate‘s Department of Urology for details: 315-464-1500.