Kidney Cancer Clinical Trial

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

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.

View Eligibility Criteria

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:

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

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.
Age > 18 years.
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:

Histologically confirmed diagnosis of urothelial carcinoma. Non-transitional cell carcinoma (such as adenocarcinoma and squamous cell carcinoma) allowed.
Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan

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.
Age > 18 years.
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 is for people with:

Kidney Cancer

Estimated Enrollment:

300

Study ID:

NCT02978118

Recruitment Status:

Recruiting

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Monika Anand, PhD
Contact
919-681-8838
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Estimated Enrollment:

300

Study ID:

NCT02978118

Recruitment Status:

Recruiting

Sponsor:


Duke University

How clear is this clinincal trial information?

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