Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02978118
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Carcinoma, Renal Cell Carcinoma, Urothelial Device: Immune cell and CTC detection procedures

Layout table for study information
Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immune Checkpoint Inhibitors in Genitourinary Malignancies
Actual Study Start Date : March 7, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Group/Cohort Intervention/treatment
Group A
Subjects in Group A (patients with metastatic renal cell carcinoma starting immune therapy) will have PBMC, plasma storage and analysis for immune cell profiles at baseline, 4 weeks, 12 weeks, and upon disease progression on treatment. Patients will have CTC assessment at baseline, 4 weeks, and upon disease progression. Urinary specimens will be collected at baseline, 4 weeks, 12 weeks, and disease progression. Fecal specimens will be collected at baseline (within 3 days of cycle 1 day 1), 4 weeks, and upon disease progression.
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
Subjects in Group B (patients with metastatic urothelial carcinoma) will have PBMC and plasma storage and analysis for immune cell profiles at baseline, 4 weeks, 12 weeks, and upon disease progression on treatment. Patients will have CTC assessment at baseline, 4 weeks, and disease progression. Urinary specimens will be collected at baseline, 4 weeks, 12 weeks, and disease progression. Fecal specimens will be collected at baseline (within 3 days of cycle 1 day 1), 4 weeks, and upon disease progression.
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)




Primary Outcome Measures :
  1. Change in the number of T-cells before and after treatment with immune therapies [ Time Frame: Baseline and Disease progression (up to two years) ]
  2. Change in the number of B-cells before and after treatment with immune therapies [ Time Frame: Baseline and Disease progression (up to two years) ]
  3. Change in the number of myeloid cells before and after treatment with immune therapies [ Time Frame: Baseline and Disease progression (up to two years) ]
  4. Number of patients with detectable circulating tumor cells (CTCs) [ Time Frame: Disease progression (up to two years) ]

Secondary Outcome Measures :
  1. The prevalence of tumor-infiltrating lymphocytes for all subjects at baseline [ Time Frame: Baseline ]
  2. The prevalence of tumor-associated macrophages for all subjects at baseline [ Time Frame: Baseline ]
  3. The change in CTCs over time [ Time Frame: Baseline, week 4, week 8, week 12 and progression (up to two years) ]
  4. The distribution of CTCs difference scores across the ordered tumor response categories of CR, PR, SD, and PD [ Time Frame: Disease progression (up to two years) ]
  5. The change in tumor burden over time measured by RECIST [ Time Frame: Baseline, Week 12, Progression (up to two years) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Duke Cancer Institute Patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978118


Contacts
Layout table for location contacts
Contact: Monika Anand, PhD (919) 681-8838 monika.anand@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Monika Anand, PhD    919-681-8838    monika.anand@duke.edu   
Sponsors and Collaborators
Duke University
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: Tian Zhang, MD Duke University

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02978118     History of Changes
Other Study ID Numbers: Pro00076768
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Neoplastic Cells, Circulating
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases