Purpose of this Study
We are doing this study to compare the usual treatment alone (treatment with ipilimumab and nivolumab followed by nivolumab alone) to the usual treatment with ipilimumab and nivolumab, follwed by nivolumab and cabozantinib.
Who Can Participate?
Eligibility
Adults 18 years or older with metastatic untreated renal cell cancer who:
- Have histologic diagnosis of renal cell carcinoma with clear cell component
- Have measurable disease
- Are not pregnant or nursing
- Have histologic diagnosis of renal cell carcinoma with clear cell component
- Have measurable disease
- Are not pregnant or nursing
What is Involved?
If you agree to be in the study you will:
- Be treated with a combination immunotherapy of nivolumab and ipilimumab.
- Have a scan and further treatment will be determined by the results of the scan.
-- Group A: Patients will get nivolumab by IV every four weeks until disease worsens.
-- Group B: Patients will get nivolumab by IV every four weeks in combination with cabozantinib taken by mouth, until disease worsens.
- Be treated with a combination immunotherapy of nivolumab and ipilimumab.
- Have a scan and further treatment will be determined by the results of the scan.
-- Group A: Patients will get nivolumab by IV every four weeks until disease worsens.
-- Group B: Patients will get nivolumab by IV every four weeks in combination with cabozantinib taken by mouth, until disease worsens.
Study Details
Principal Investigator
Jeffrey
Crawford
Protocol Number
PRO00102937
NCT ID
NCT03793166
Phase
III
Enrollment Status
OPEN TO ACCRUAL