Blood, Tissue, Urine, and Stool Samples in Learning about Immune-Based Biomarkers and Circulating Tumor Cells in Patients with Metastatic Kidney or Urothelial Cancer Receiving Immunotherapy

PRIMARY OBJECTIVES:

I. To describe peripheral circulating immune cell profiles at baseline and change on treatment with immune checkpoint inhibitors in renal cell carcinoma and urothelial carcinoma.

SECONDARY OBJECTIVES:

I. To describe the circulating tumor cells for renal cell carcinoma and urothelial carcinoma at baseline and change on treatment with immunotherapy in renal cell carcinoma and urothelial carcinoma.

II. To describe the tumor-infiltrating immune cells from primary cancers obtained from either nephrectomy or cystectomy.

III. To describe the expression (prevalence) of immune checkpoint ligands PD-L1, PD-L2, and B7-H3 on primary cancers obtained from either nephrectomy or cystectomy.

IV. To characterize the baseline gastrointestinal and urinary microbiome in patients with metastatic renal cell carcinoma (RCC) and urothelial carcinoma (UC) treated with PD-1 inhibitors in association with clinical response.

V. To evaluate changes in the gastrointestinal and urinary microbiome in patients with metastatic RCC and UC over time during treatment with PD-1 inhibitors.

VI. To evaluate baseline radiographic characteristics and changes on treatment with checkpoint inhibitors, to identify characteristics associated with response versus resistance to treatment.

OUTLINE:

Patients undergo collection of blood, urine, and stool samples at baseline (within 3 days of course 1, day 1 for stool samples), 4, and 12 weeks, and upon disease progression after starting standard of care immunotherapy. Blood samples are analyzed for circulating immune cells by flow cytometry and peptide microarray, and circulating tumor cells (CTCs). Urine samples undergo microbiome analysis as well as analysis of immune cell and cytokine environment by flow cytometry and enzyme-linked immunosorbent assay (ELISA). Stool samples undergo microbial deoxyribonucleic acid (DNA) analysis. Previously collected tissue samples are analyzed for tumor infiltrating lymphocytes (TILs), tumor-associated macrophages (TAMs), PD-L1, PD-L2, and B7-H3 expression by immunohistochemistry (IHC). All samples may also undergo additional analyses to biomarkers, factors or immune components related to the use of immunotherapy in RCC and UC.