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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Carcinoma
• Renal Cell
• Carcinoma
• Urothelial

ELIGIBILITY

Inclusion Criteria:
Group A Renal Cell Carcinoma:
Patients will be eligible for inclusion in this study if ALL of the following criteria apply:
1. Histologically confirmed or radiological diagnosis of renal cell carcinoma. Clear cell and non-clear cell carcinoma (such as papillary, chromophobe, collecting duct, and medullary) allowed.

- 2. Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan

- 3. Planned initiation of treatment with any of the following:
* Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)

- * Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.

- 4. Age > 18 years.

- 5. Ability to understand and the willingness to sign a written informed consent document.
Group B Urothelial Carcinoma:
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 locally advanced, high grade or metastatic disease in any site on most recent imaging scan

- 3. Planned initiation of treatment with any of the following:
* Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)

- * Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.

- 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 condition that would make participation in this protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Tian Zhang, MD

Role: Principal Investigator

Affiliation: Duke University

Overall Contact

Name: Monika Anand, PhD

Phone: (919) 681-8838

Email: monika.anand@duke.edu

LOCATION