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Brief Title: Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immune Checkpoint Inhibitors in Genitourinary Malignancies (CTC Immune Based Biomarkers)

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

INTRODUCTION

  • Org Study ID: Pro00076768
  • Secondary ID: N/A
  • NTC ID: NCT02978118
  • 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.


  • Overall Status
    Recruiting
  • Start Date
    March 7, 2017
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Change in the number of T-cells before and after treatment with immune therapies

Primary Outcome 1 - Timeframe: Baseline and Disease progression (up to two years)

Primary Outcome 2 - Measure: Change in the number of B-cells before and after treatment with immune therapies

Primary Outcome 2 - Timeframe: Baseline and Disease progression (up to two years)

Primary Outcome 3 - Measure: Change in the number of myeloid cells before and after treatment with immune therapies

Primary Outcome 3 - Timeframe: Baseline and Disease progression (up to two years)

Primary Outcome 4 - Measure: Number of patients with detectable circulating tumor cells (CTCs)

Primary Outcome 4 - Timeframe: Disease progression (up to two years)

CONDITION

  • Carcinoma
  • Renal Cell
  • Carcinoma
  • Urothelial

ELIGIBILITY


Inclusion Criteria:

Group A:

Patients will be eligible for inclusion in this study if ALL of the following criteria
apply:

1. Histologically confirmed diagnosis of renal cell carcinoma. Clear cell and non-clear
cell carcinoma (such as papillary, chromophobe, collecting duct, and medullary)
allowed.

2. Evidence of metastatic disease in any site on most recent imaging scan

3. Planned initiation of treatment with immune modulatory agent targeting any of the
following: PD-1, PD-L1, CTLA-4, CD27, OX40, or LAG3

4. Age > 18 years.

5. Ability to understand and the willingness to sign a written informed consent document.

Group B:

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 metastatic disease in any site on most recent imaging scan

3. Planned initiation of treatment with immune modulatory agent targeting any of the
following: PD-1, PD-L1, CTLA-4, CD27, OX40, or LAG3

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 medical or psychiatric illness that would make
participation in a blood drawing protocol difficult or not feasible at the discretion
of the principal investigator or co-investigator(s).

2. Treatment with systemic steroids of any dose or formulation (including hydrocortisone,
prednisone, methylprednisolone (Solumedrol), dexamethasone), within 4 weeks of consent
or planned initiation of steroids after consent (unplanned steroid initiation for
treatment of immune related adverse events is allowed). Chronic treatment with
steroids for physiological replacement for adrenal insufficiency is allowed.

3. Treatment with immunosuppressive agents (including mycophenolate mofetil (Cellcept),
mycophenolate sodium (Myfortic), rituximab (Rituxan), tacrolimus (Prograf), sirolimus
(Rapamune), cyclosporine (Sandimmune), TNF-a inhibitors such as infliximab, etanercept
or adalimumab, methotrexate, azathioprine, and dactinomycin) within 4 weeks of consent
or planned initiation of any of these agents for 12 weeks after consent.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Tian Zhang, MD

Role: Principal Investigator

Affiliation: Duke University

Overall Contact

Name: Tian Zhang, MD

Phone: (919) 681-8838

Email: monika.anand@duke.edu

LOCATION

Facility Status Contact
Facility: Duke University Medical Center
Durham, North Carolina 27710
United States 		Status: Recruiting Contact:
Monika Anand, PhD
919-681-8838
monika.anand@duke.edu

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