Inclusion Criteria:

- completely resected advanced high-risk RCC

- T3b-c, T4, or N1-2, or M1 disease resected to no evidence of disease (AJCC-TNM, 2002)
Patients must have recovered from any effects of surgery, which must have been -
excellent performance status (Eastern Cooperative Oncology Group performance status
of 0 or 1);

- adequate organ function defined as WBC count 4,000/µL, platelet count 100,000/µL,
hemoglobin 10 g/dL, serum creatinine 1.5 mg/dL or creatinine clearance 60 mL/min, and
direct bilirubin 1.5 mg/dL; and forced expiratory volume at 1 second more than 2.0 L
or 75% of predicted for height and age from pre-enrollment pulmonary function testing

- age 18 years and older

Exclusion Criteria:

- history or evidence of cardiac disease on ECG or autoimmunity

- prior systemic treatment for RCC

- history of invasive malignancy in the past 5 years or human immunodeficiency virus
positivity

- positive pregnancy test