A Study to Test the Safety and Feasibility of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Liver Cancer

Inclusion Criteria:

- Age 18 and over at the time of consent

- Histology and/or cytology confirmed HCC per the enrolling institution

- Measurable disease per RECIST v1.1

- Disease not amenable to curative or transplant surgery (BCLC Stage B); disease must be
reviewed by members of disease management team at the local enrolling institution and
be amenable to deb-TACE to treat all sites of disease in one session

- ECOG Performance status 0 or 1

- Child-Pugh Class A

- Adequate bone marrow, hepatic, and renal function defined as:

- Platelet count ≥ 75,000/mm3

- Absolute neutrophil count ≥ 1,000/mm3

- Hemoglobin ≥ 9 g/dL

- Total bilirubin < 3.0 × ULN (upper limit of normal)

- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 × ULN

- Albumin ≥ 2.8 g/dL

- Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 40 mL/min as
determined by the Cockcroft-Gault equation

- Suppression of HBV (≤ 100 IU/mL by HBV PCR) with antivirals per the local standard of
care if prior or current HBV exposure or infection.

- Active HCV infection without treatment is permitted. Concomitant treatment of HCV is
not permitted on this study.

Exclusion Criteria:

- Vascular invasion or extrahepatic spread

- History of liver allograft; prior hepatic resection is allowed.

- Prior embolization and/or ablation

- Contraindication to angiography/embolization procedure based on judgment of the
treating investigator.

- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or
any other antibody or drug specifically targeting T-cell costimulation or immune
checkpoint pathways

- Known history of testing positive for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS)

- A history of a severe contrast allergy (.i.e. anaphylaxis) not controlled with
premedication

- Patients should be excluded if they have a condition requiring chronic systemic
treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other
immunosuppressive medications within 14 days of study drug administration. Inhaled or
topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents
are permitted in the absence of active autoimmune disease. Patients with contrast
allergies who can tolerate contrast with corticosteroid premedication are not
excluded.

- An active, known or suspected autoimmune disease. Subjects are permitted to enroll if
they have 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.

- Subjects with history of another primary cancer, with the exception of: a) curatively
resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ;
or c) other primary solid tumor with no known active disease present that in the
opinion of the investigator will not affect patient outcome in the setting of current
HCC diagnosis.

- Any condition that, in the opinion of the investigator, would interfere with
evaluation of the investigational product or interpretation of subject safety or study
results

- Women of childbearing potential (WOCBP) or sexually active men must use appropriate
method(s) of contraception.

- Women of childbearing potential (WOCBP) must use appropriate method(s) of
contraception while on study treatment. WOCBP should use an adequate method to
avoid pregnancy during study treatment and for 5 months (30 days plus the time
required for nivolumab to undergo five half-lives) after the last dose of
investigational drug

- Men who are sexually active with WOCBP must use any contraceptive method with a
failure rate of less than 1% per year Men receiving nivolumab and who are
sexually active with WOCBP will be instructed to adhere to contraception during
study treatment and for a period of 7 months after the last dose of
investigational product

- Women who are not of childbearing potential (ie, who are postmenopausal or
surgically sterile, as well as azoospermic men do not require contraception

- Women of childbearing potential must have a negative serum or urine pregnancy test
(minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the
start of nivolumab. Elevated HCG for other explained and documented reasons is
allowed.

- Lactating woman