This phase I trial studies the side effects of nivolumab and ipilimumab with embolization in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Embolization therapy injects tiny particles into the arteries feeding tumors to cut off their blood supply. This trial is being done to find out if killing the primary tumor in the kidney stimulates the immune system and improves the effect of the nivolumab and ipilimumab on metastases elsewhere in the body.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04429321.
PRIMARY OBJECTIVE:
I. To evaluate the safety of embolotherapy in patients with metastatic renal cell carcinoma (RCC) receiving immune checkpoint inhibition (ICI) therapy.
SECONDARY OBJECTIVES:
I. To investigate anti-tumor efficacy of ICI therapy in combination with immunostimulatory tumor embolization as measured by objective response rate.
II. Characterize change in infiltrating immune cells in peripheral blood, primary and metastatic tumor sites before and after immunostimulatory embolization.
III. Characterize exosomal PD-L1 expression as a biomarker of response or resistance to immunotherapy.
OUTLINE:
Patients receive nivolumab intravenously (IV) and ipilimumab IV every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV every 4 weeks for 6 months in the absence of disease progression or unacceptable toxicity. After completion of first 2 cycles of nivolumab and ipilimumab, patients undergo embolization of the kidney tumor or metastasis.
After completion of study treatment, patients are followed up at 30 days.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorMichael C. Soulen
