The ADAPT clinical study is a randomized trial, where two out of three patients enrolled will receive a combination treatment of AGS-003 plus a first-line targeted therapy, starting with Sutent (sunitinib), a well established initial treatment for patients with advanced kidney cancer. The remaining one-third will receive the same standard treatment beginning with sunitinib alone (control arm).
AGS-003 and sunitinib (Combination Arm)
Patients who are assigned to receive both AGS-003 and sunitinib will undergo a standard leukapheresis procedure to capture the white blood cells needed to create AGS-003. These patients will then start the first 6-week course of sunitinib prior to receiving their first dose of AGS-003.
If patients do not respond well to sunitinib either because of side effects or disease progression (during the first year of study treatment), their oncologists have the flexibility to switch to another standard, approved targeted drug therapy.
After 6 weeks of targeted therapy beginning with sunitinib, patients are scheduled to receive 8 doses of AGS-003 during the first year of participation. For those continuing to benefit after the first year of treatment, booster doses of AGS-003 will be given every 3 months thereafter, in combination with standard targeted therapy.
Best Available Care (Control Arm)
One third of trial patients will receive targeted drug therapy alone, as they would outside of the trial. These patients will not undergo the leukapheresis procedure and will instead start with a standard 6-week cycle of sunitinib alone. They will continue sunitinib or other targeted therapies alone, while receiving study directed treatment.