Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC

The purpose of this non-treatment, non-interventional protocol is to collect, preserve, and
store excess tumor specimens, which would otherwise be discarded, following routine
nephrectomy for subjects with advanced renal cell carcinoma (RCC). The collected tumor
specimen will be preserved under current Good Manufacturing Practice conditions and will not
be used for any other research or therapeutic purpose without a separate consent from the
subject, specific to the intended use on a separate Institutional Review Board or
Institutional Ethics Committee approved Argos sponsored study.

Following routine nephrectomy (partial or cytoreductive) as indicated for subjects with
advanced RCC, small samples of the excised tumor will be sectioned and placed into an RNA
preservative solution as supplied by the sponsor. After collection, this preserved tumor
specimen will be shipped to a repository operating under current Good Manufacturing Practice
conditions. The tumor specimen will be stored for no longer than five years unless
subsequent consent is obtained for extended storage or other use.

Inclusion Criteria:

- 1. Age ≥ 18 years

- 2. Diagnosis or clinical signs of advanced RCC (Stage III or IV RCC; Refer to
Appendix A)

- 3. Scheduled for cytoreductive or partial (unilateral or bilateral) nephrectomy

- 4. Signed and dated informed consent document indicating that the subject (or legally
acceptable representative) has been informed of all pertinent aspects of tumor
specimen collection prior to enrollment

Exclusion Criteria:

- 1. Evidence of brain metastases prior to nephrectomy

- 2. Requirement for systemic chronic immunosuppressive drugs or systemic chronic
corticosteroids, for active autoimmune disorder(s) or other conditions (e.g.:
rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ
transplant recipient, etc.)

- 3. History of HIV infection, or history of chronic infection with Hepatitis B or
Hepatitis C