Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immune Checkpoint Inhibitors in Genitourinary Malignancies (CTC Immune Based Biomarkers)
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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)
|
Outcome Measures
Primary Outcome Measures
- 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)]
- Change in the number of myeloid 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
- 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 change in CTCs over time [Baseline, week 4, week 8, week 12 and progression (up to two years)]
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
Group A:
Patients will be eligible for inclusion in this study if ALL of the following criteria apply:
-
Histologically confirmed diagnosis of renal cell carcinoma. Clear cell and non-clear cell carcinoma (such as papillary, chromophobe, collecting duct, and medullary) allowed.
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Evidence of metastatic disease in any site on most recent imaging scan
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Planned initiation of treatment with immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, or LAG3
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Age > 18 years.
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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:
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Histologically confirmed diagnosis of urothelial carcinoma. Non-transitional cell carcinoma (such as adenocarcinoma and squamous cell carcinoma) allowed.
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Evidence of metastatic disease in any site on most recent imaging scan
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Planned initiation of treatment with immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, or LAG3
-
Age > 18 years.
-
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:
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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).
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
- University of Wisconsin, Madison
Investigators
- Principal Investigator: Tian Zhang, MD, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00076768