CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy and Targeted Kinase Inhibition
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Kidney Cancer
- Renal Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Intervention Model: Sequential AssignmentIntervention Model Description: The first three to six subjects (group 1) will have the cabozantinib held for three weeks prior to removal of the kidney. If there are no unexpected side effects from the surgery, then future subjects (group 2) will have the cabozantinib stopped for two weeks prior to the nephrectomy.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 in order to decrease the amount of tumor in the body. This sur...
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 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 is being administered in combination with cabozantinib. Both of these drugs are FDA approved medications for the treatment of metastatic kidney cancer. Previous studies have demonstrated that these two medications can be combined together without significantly increasing the side effects beyond what is expected from each medicine individually. The combination of nivolumab and cabozantinib for the treatment of metastatic kidney cancer is an investigational regimen and not FDA approved for the treatment of kidney cancer.
Tracking Information
- NCT #
- NCT04322955
- Collaborators
- Exelixis
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Mark N Stein, MD Associate Professor of Medicine Division of Hematology/Oncology
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