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

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

Non Recruiting
18 years and older
All
Phase N/A

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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).

Study details
    Carcinoma
    Renal Cell
    Carcinoma
    Urothelial

NCT02978118

Duke University

21 October 2025

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