||Phase III (Cancer Control)
|Secondary Protocol No.
||An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
||The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
||Experimental: AGS-003 + Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.
Active Comparator: Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma
||This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma.
||Patient must have a diagnosis or clinical signs of advanced RCC as defined by TNM classification of [any T, any N, M1].
|Applicable Disease Sites
||Cell Cycle Inhibitor
||Masonic Cancer Center
||Patient must be at least 18 years of age and scheduled for unilateral or partial nephrectomy. Anyone with known brain metastases prior to nephrectomy or has a requirement for systemic chronic immunosuppressive drugs or corticosteroids is not eligible. Women who are pregnant or nursing are not eligible for treatment study. A signed informed consent and HIPAA authorization are required.