Clinical trial NCT02978118: Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies (CTC Immune Based Biomarkers)
Official title: Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Renal Cell
Carcinoma, Urothelial
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
First posted: 2016-11-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Duke Cancer Institute Patients

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in the number of T-cells before and after treatment with immune therapies
timeFrame: Baseline and Disease progression (up to two years)
measure: Change in the number of B-cells before and after treatment with immune therapies
timeFrame: Baseline and Disease progression (up to two years)
measure: Change in the number of myeloid-derived suppressor cells (MDSCs) before and after treatment with immune therapies
timeFrame: Baseline and Disease progression (up to two years)
measure: Change in the number of neutrophil cells before and after treatment with immune therapies
timeFrame: Baseline and Disease progression (up to two years)
measure: Number of patients with detectable circulating tumor cells (CTCs)
timeFrame: Disease progression (up to two years)
Secondary outcomes:
measure: The prevalence of tumor-infiltrating lymphocytes for all subjects at baseline
timeFrame: Baseline
measure: The prevalence of tumor-associated macrophages for all subjects at baseline
timeFrame: Baseline
measure: The change in CTCs over time
timeFrame: Baseline, week 4, week 8, week 12 and progression (up to two years)
measure: The distribution of CTCs difference scores across the ordered tumor response categories of CR, PR, SD, and PD
timeFrame: Disease progression (up to two years)
measure: The change in tumor burden over time measured by RECIST
timeFrame: Baseline, Week 12, Progression (up to two years)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Shahla Bari, MBBS
role: PRINCIPAL_INVESTIGATOR
References: