Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma, Renal Cell
- Sponsor
- Duke University
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Change in the number of T-cells before and after treatment with immune therapies
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
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:
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).
Outcomes
Primary Outcomes
Change in the number of T-cells before and after treatment with immune therapies
Time Frame: Baseline and Disease progression (up to two years)
Change in the number of B-cells before and after treatment with immune therapies
Time Frame: Baseline and Disease progression (up to two years)
Change in the number of myeloid-derived suppressor cells (MDSCs) before and after treatment with immune therapies
Time Frame: Baseline and Disease progression (up to two years)
Change in the number of neutrophil cells before and after treatment with immune therapies
Time Frame: Baseline and Disease progression (up to two years)
Number of patients with detectable circulating tumor cells (CTCs)
Time Frame: Disease progression (up to two years)
Secondary Outcomes
- The prevalence of tumor-associated macrophages for all subjects at baseline(Baseline)
- The distribution of CTCs difference scores across the ordered tumor response categories of CR, PR, SD, and PD(Disease progression (up to two years))
- The change in tumor burden over time measured by RECIST(Baseline, Week 12, Progression (up to two years))
- The prevalence of tumor-infiltrating lymphocytes for all subjects at baseline(Baseline)
- The change in CTCs over time(Baseline, week 4, week 8, week 12 and progression (up to two years))