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

Recruiting

• Conditions: Carcinoma, Urothelial; Carcinoma, Renal Cell
• Interventions: Device: Immune cell and CTC detection procedures

• Registration Number: NCT02978118
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-30
• Study Start: 2017-03-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-20
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: Renal Cell Carcinoma	Immune cell and CTC detection procedures	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).
Group B: Urothelial Carcinoma	Immune cell and CTC detection procedures	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).

Primary Outcome Measures

Name	Time	Method
Change in the number of myeloid cells before and after treatment with immune therapies	Baseline and Disease progression (up to two years)
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)

Secondary Outcome Measures

Name	Time	Method
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 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 change in CTCs over time	Baseline, week 4, week 8, week 12 and progression (up to two years)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States