Inclusion criteria:

• Signed Informed Consent Form
• Able to comply with the treatment schedule
• Histologically confirmed Stage IV renal-cell carcinoma (AJCC) with lung and/or soft tissue metastases after nephrectomy
• ECOG performance status 0 or 1
• Measurable disease by Recist criteria (as defined in Section 8.1) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ³ 20 mm with conventional techniques, or as ³ 10 mm with spiral CT scan
• > 18 years of age
• Must have adequate bone marrow reserve: hemoglobin ³10 g/dL; platelet count > 100,000 mm3 ; neutrophils ³ 1000/ mL
• Must have adequate renal function: serum creatinine ≤ 2.0 mg/dL.
• Must have adequate hepatic function: bilirubin ≤ 1.5 mg/dL; SGOT/SGPT <3x upper limit of normal
• Activated partial thromboplastin time ≤ 40 seconds
• Serum calcium within normal limits based on laboratory criteria
• Predominant clear cell histology
• Patients of reproductive potential must agree to use an effective (>90% reliability) form of birth control during the study and for 4 weeks following the last study drug administration. (All patients and their partners)
• Life expectancy of greater than 4 months

Exclusion Criteria:

• Pre-existing autoimmune or antibody-mediated diseases including: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia. Controlled thyroid disease or the presence of auto-antibodies without clinical autoimmune disease are permissible
• Known history of HIV
• CNS, bone or liver metastases
• Tumors that are mainly papillary, chromophobe, medullary, collecting duct, or unclassified, are to be excluded
• Prior malignancy except basal cell or non-invasive squamous cell carcinoma of the skin or in situ squamous cell carcinoma of the cervix
• History of allergic reactions attributed to compounds of similar composition to CpG 7909
• Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction less than 40%
• Recipients of solid organ allografts
• Prior splenectomy
• Prior immunotherapy, including IL-2 or IFN-alpha
• Any prior therapy for renal cell cancer except for surgery
• Prior chemotherapy
• Prior radiation therapy to 25 percent or more of the bone marrow
• Systemic corticosteroids or immunosuppressants and anticoagulants (except for aspirin ≤ 325 mg per day)
• Acute infection requiring antibiotics and/or fever over 38.2° C within 3 days prior to study entry
• Pregnant or lactating
• Participation in an investigational drug trial within 30 days prior to screening
• Any other medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results
• Suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse deemed by the investigator to be likely to effect their ability to sign the informed consent, and undergo study procedures
• Hepatitis B or C (active, prior treated, or both)