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

Introduction

• Org Study ID: Pro00076768
• NTC ID: NCT02978118
• Lead Sponsor Name: Duke University
• Status: RECRUITING

Conditions

• Chromophobe Renal Cell Carcinoma
• Clear Cell Renal Cell Carcinoma
• Collecting Duct Renal Cell Carcinoma
• Papillary Renal Cell Carcinoma
• Renal Medullary Carcinoma

Brief Summary

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 Criteria

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).