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

Duke University

Status: Active, not recruiting

Conditions: Carcinoma, Renal Cell; Carcinoma, Urothelial

Treatments: Device: Immune cell and CTC detection procedures

Study type: Observational

Funder types: Other

Identifiers

NCT02978118

Pro00076768

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

67 participants in 2 patient groups

Group A: Renal Cell Carcinoma

Description:

Subjects in Group A (patients with locally advanced, high grade or metastatic renal cell carcinoma starting immunotherapy) will have blood collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression on treatment for analysis of peripheral blood mononuclear cells (PBMCs), circulating tumor cells (CTCs), metabolites, cytokines and angiokines. Urinary and fecal specimens will be collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression. Tissue will be collected at the time of a standard of care cytoreductive surgery (if applicable).

Treatment:

Device: Immune cell and CTC detection procedures

Group B: Urothelial Carcinoma

Description:

Subjects in Group B (patients with locally advanced, high grade or metastatic urothelial carcinoma starting immunotherapy) will have blood collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression on treatment for analysis of peripheral blood mononuclear cells (PBMCs), circulating tumor cells (CTCs), metabolites, cytokines and angiokines. Urinary and fecal specimens will be collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression. Tissue will be collected at the time of a standard of care cytoreductive surgery (if applicable).

Treatment:

Device: Immune cell and CTC detection procedures