Overview
This pilot study purpose of this study is to describe peripheral circulating immune cell profiles at baseline and change on treatment with immune checkpoint inhibitors in renal cell carcinoma and urothelial carcinoma.
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).