Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immune Checkpoint Inhibitors in Genitourinary Malignancies (CTC Immune Based Biomarkers)

Inclusion Criteria:

Group A:

Patients will be eligible for inclusion in this study if ALL of the following criteria
apply:

1. Histologically confirmed diagnosis of renal cell carcinoma. Clear cell and non-clear
cell carcinoma (such as papillary, chromophobe, collecting duct, and medullary)
allowed.

2. Evidence of metastatic disease in any site on most recent imaging scan

3. Planned initiation of treatment with immune modulatory agent targeting any of the
following: PD-1, PD-L1, CTLA-4, CD27, OX40, or LAG3

4. Age > 18 years.

5. Ability to understand and the willingness to sign a written informed consent document.

Group B:

Patients will be eligible for inclusion in this study if ALL of the following criteria
apply:

1. Histologically confirmed diagnosis of urothelial carcinoma. Non-transitional cell
carcinoma (such as adenocarcinoma and squamous cell carcinoma) allowed.

2. Evidence of metastatic disease in any site on most recent imaging scan

3. Planned initiation of treatment with immune modulatory agent targeting any of the
following: PD-1, PD-L1, CTLA-4, CD27, OX40, or LAG3

4. Age > 18 years.

5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria
apply:

1. History of intercurrent or past medical or psychiatric illness that would make
participation in a blood drawing protocol difficult or not feasible at the discretion
of the principal investigator or co-investigator(s).

2. Treatment with systemic steroids of any dose or formulation (including hydrocortisone,
prednisone, methylprednisolone (Solumedrol), dexamethasone), within 4 weeks of consent
or planned initiation of steroids after consent (unplanned steroid initiation for
treatment of immune related adverse events is allowed). Chronic treatment with
steroids for physiological replacement for adrenal insufficiency is allowed.

3. Treatment with immunosuppressive agents (including mycophenolate mofetil (Cellcept),
mycophenolate sodium (Myfortic), rituximab (Rituxan), tacrolimus (Prograf), sirolimus
(Rapamune), cyclosporine (Sandimmune), TNF-a inhibitors such as infliximab, etanercept
or adalimumab, methotrexate, azathioprine, and dactinomycin) within 4 weeks of consent
or planned initiation of any of these agents for 12 weeks after consent.