Cyto-KIK; TRIAL (CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy (Nivolumab) and Targeted Kinase Inhibition (Cabozantinib)
Mark Stein
Summary
The purpose of this study is to determine if the use of immunotherapy nivolumab and the targeted therapy cabozantinib prior to removal of the kidney, will increase the number subjects who are without any visible kidney cancer in their body at some point during the course of treatment.
Description
People with metastatic kidney cancer are usually treated with medications to slow the growth of the cancer. In addition, people who still have the kidney where the cancer started may have the kidney removed during the course of treatment. This surgery is done in order to decrease the amount of tumor in the body. This surgery is referred to as a cytoreductive nephrectomy. In the current study, nivolumab, an immune checkpoint inhibitor, is being administered in combination with cabozantinib, a targeted therapy. The combination of nivolumab and cabozantinib is FDA approved for the treatment of me…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information. 2. Age ≥ 18years at the time of consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 within 28 days prior to registration. 4. Radiographically consistent with metastatic renal cell carcinoma (with subsequent pathologic confirmation of renal cell carcinoma with a clear cell component) OR histological/ cytological evidence of metastatic renal cell carcinoma with a clear cell component 5. Measurable tumor in the kidney according to RECIST 1.1 6. No prior…
Interventions
- DrugCabozantinib
2 x 20 mg capsules taken orally daily
- DrugNivolumab
480mg IV on first day of each 28-day cycle
- ProcedureCytoreductive nephrectomy
Surgery removing as much tumor tissue as possible, possibly including surrounding tissues.
Locations (4)
- The Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey
- Columbia University Irving Medical CenterNew York, New York
- Cleveland ClinicCleveland, Ohio
- Ohio State University Wexner Medical CenterColumbus, Ohio