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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Carcinoma, Renal Cell; Carcinoma, Urothelial
• Intervention / Treatment: Device: Immune cell and CTC detection procedures

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Duke Cancer Institute Patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A: Renal Cell Carcinoma; 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).	Device: Immune cell and CTC detection procedures; Immune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples)
Group B: Urothelial Carcinoma; 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).	Device: Immune cell and CTC detection procedures; Immune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples)

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Number of patients with detectable circulating tumor cells (CTCs)	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)

Secondary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of Wisconsin, Madison
• Investigators: Principal Investigator: Daniel George, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2017
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimated): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Kidney Neoplasms; Carcinoma; Carcinoma, Renal Cell
• Other Study ID Numbers: Pro00076768

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No