Exploring immune biomarkers and tumor cells in kidney and bladder cancer treatment
Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies
This study is trying to see how certain immune cells and tumor cells in people with kidney and bladder cancer affect their response to new immune treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT02978118 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the profiles of circulating immune cells and tumor cells in patients with renal cell carcinoma and urothelial carcinoma who are undergoing treatment with immune checkpoint inhibitors. By assessing these immune-based biomarkers at baseline and during treatment, the study seeks to understand how these factors may influence treatment responses. The study will involve patients who are starting therapy with various immune modulatory agents, allowing for a comprehensive evaluation of immune responses in these cancers.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with confirmed renal cell carcinoma or urothelial carcinoma who are starting treatment with immune modulatory agents.
Not a fit: Patients with early-stage or non-metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of immune responses in cancer treatment, potentially enhancing patient outcomes.
How similar studies have performed: Other studies have shown promise in using immune biomarkers to predict treatment responses, suggesting this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Shahla Bari, MBBS — Duke University
- Study coordinator: Shahla Bari, MBBS
- Email: shahla.bari@duke.edu
- Phone: 919-681-7460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.