Carcinoma, Renal Cell, Carcinoma, Urothelial
Conditions
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.
Interventions
DEVICEImmune cell and CTC detection procedures
Immune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples)
Sponsors
Duke University
University of Wisconsin, Madison
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the number of T-cells before and after treatment with immune therapies | Baseline and Disease progression (up to two years) |
| Change in the number of B-cells before and after treatment with immune therapies | 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 | Baseline and Disease progression (up to two years) |
| Change in the number of neutrophil cells before and after treatment with immune therapies | Baseline and Disease progression (up to two years) |
| Number of patients with detectable circulating tumor cells (CTCs) | Disease progression (up to two years) |
Secondary
| Measure | Time frame |
|---|---|
| The prevalence of tumor-infiltrating lymphocytes for all subjects at baseline | Baseline |
| The prevalence of tumor-associated macrophages 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) |
| 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel George, MD
Duke University
Outcome results
None listed