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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02978118
• Other study ID #: Pro00076768
• Status: Recruiting
• Start date: March 7, 2017
• Est. completion date: October 2028

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: Monika Anand, PhD
• Phone: (919) 681-8838
• Email: monika.anand[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2028
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Carcinoma, Urothelial
• Neoplastic Cells, Circulating

Intervention

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)

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of T-cells before and after treatment with immune therapies		Baseline and Disease progression (up to two years)
Primary	Change in the number of B-cells before and after treatment with immune therapies		Baseline and Disease progression (up to two years)
Primary	Change in the number of myeloid cells before and after treatment with immune therapies		Baseline and Disease progression (up to two years)
Primary	Number of patients with detectable circulating tumor cells (CTCs)		Disease progression (up to two years)
Secondary	The prevalence of tumor-infiltrating lymphocytes for all subjects at baseline		Baseline
Secondary	The prevalence of tumor-associated macrophages for all subjects at baseline		Baseline
Secondary	The change in CTCs over time		Baseline, week 4, week 8, week 12 and progression (up to two years)
Secondary	The distribution of CTCs difference scores across the ordered tumor response categories of CR, PR, SD, and PD		Disease progression (up to two years)
Secondary	The change in tumor burden over time measured by RECIST		Baseline, Week 12, Progression (up to two years)