The purpose of this study is to see if continued nivolumab with the addition of ipilimumab plus hypo-fractionated stereotactic radiation (sTR) of a single lesions results in partial or complete responses in patients with metastatic ccRCC who fail initial treatment with single agent nivolumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Nivolumab will be given every 21 days for the first 12 weeks at a dose of 3mg/kg. After 12 weeks, the dose will be 240mg and will be given every 14 days.
Ipilimumab will be given at a dose of 1mg/kg every 21 days for up to 12 weeks.
The dose of radiation will be 6 Gy daily x 5 days. Radiation will be given between the first and second doses of ipilimumab plus nivolumab.
Medical University of South Carolina
Charleston, South Carolina, United States
Number of patients with a partial or complete response
The response rate of combined ipilimumab and nivolumab plus STR will be determined using irRECIST criteria.
Time frame: 12 weeks
Progression free survival (PFS)
PFS will be determined from the onset of treatment to the time of documented disease progression.
Time frame: 2 years
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