Nivolumab and Yttrium Y 90 Glass Microspheres in Treating Patients With Advanced Liver Cancer

Inclusion Criteria

• Patients must have a diagnosis of hepatocellular carcinoma (HCC) confirmed by American Association for Study of Liver Diseases (AASLD) guidelines with a Childs-Pugh score of A or B (but, = = 8.5 g/dL (without the use of growth factors)
• Absolute neutrophil count (ANC) >= 1000
• Platelet count >= 50 x 10^9/L (without use of growth factors [ie., interleukin 11 (oprelvekin)])
• Prothrombin time (PT)/international normalized ratio (INR) = 50 mL/min (Cockcroft-Gault formula will be used to calculate CrCl)
• Hepatic
• Serum bilirubin = = 3 years before registration and felt to be at low risk for recurrence by the treating physician.
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• Adequately treated cervical carcinoma in situ without evidence of disease
• Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:
• Immune related neurologic disease
• Multiple sclerosis
• Autoimmune (demyelinating) neuropathy
• Guillain-Barre syndrome
• Myasthenia gravis
• Systemic autoimmune disease such as systemic lupus erythematosus (SLE)
• Connective tissue diseases
• Scleroderma
• Inflammatory bowel disease (IBD)
• Crohn's
• Ulcerative colitis
• Patients with a history of toxic epidermal necrolysis (TEN)
• Stevens-Johnson syndrome
• Anti-phospholipid syndrome
• NOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
• Patients with renal failure currently requiring dialysis of any kind are not eligible
• Patients with untreated central nervous system (CNS) metastatic disease (including spinal cord and leptomeningeal disease) are excluded
• Note: Subjects with previously treated CNS metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management are permitted to enroll
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study, is excluded
• Receipt of any investigational therapy is not permitted within 28 days prior to the first dose of nivolumab
• Any concurrent chemotherapy, biologic or hormonal therapy for cancer treatment is not permitted within 28 days of registration
• Note: Prior immunotherapy is not permitted
• Note: Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
• Patients with exposure to prior immunotherapy are not eligible
• Patients are ineligible if they have unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) CTCAE version 4.03 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria
• Note: Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss) after consultation with the PI and Northwestern University (NU) Quality Assurance Monitor (QAM)
• Radiation therapy is not permitted within 14 days of registration
• Live vaccines are not permitted within 28 days of study registration
• No systemic glucocorticoids will be permitted within 48 hours prior to study registration
• Note: Topical steroids, bronchodilators and local steroid injections are permitted if clinically required
• Patients with cardiac disease defined as one of