This single center phase 1 trial will study the combination of nivolumab+ipilimumab with embolization in participants with renal cell carcinoma. The study will evaluate the safety of embolotherapy in patients with metastatic RCC receiving nivolumab+ipilimumab. The hypothesis is that the number of serious adverse events will be no greater than the number of serious adverse events for both therapies combined.
Previously untreated subjects with stage 4 RCC and unresected primary tumor or metastasis amenable to embolization will undergo two cycles of combination immune checkpoint inhibition (ICI) therapy, embolization of the target tumor, then resume ICI therapy. Study ends with safety and efficacy assessment at 6 months. Correlative blood and tissue specimens will be obtained.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Nivolumab 3 mg/kg IV every four weeks, first in combination with capecitabine then alone
ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, in combination with Nivolumab
Lipiodol:ethanol embolization of their primary or target tumor
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rate of serious adverse events
SAE rate following embolization in patients
Time frame: Serious adverse events will be recorded from time of informed to consent to 100 days after the end of study intervention
Objective response rate
Objective response rate by RECIST 1.1
Time frame: Measured from baseline to 6 months post initiation
Characterization of immune cells
Characterization of tumor-infiltrating leukocytes in primary and metastatic lesions before and after embolotherapy
Time frame: From baseline to 12 weeks post initiation of therapy
PD-L1
Percentage of PD-L1 stain positivity in the primary tumor biopsy of participants
Time frame: From baseline to 12 weeks post initiation of therapy
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