Stereotactic Body Radiotherapy (SBRT) Followed by Immunotherapy in Liver Cancer

Exclusion Criteria

• •Prior external beam radiation therapy to the liver (defined as \> 1 Gy).
• •Prior yttrium-90 radioembolization treatment.
• •Patients with HBV viral load \> 100 IU/mL (antiviral therapy per local practice is required).
• •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a dose of \>10 mg prednisone daily or equivalent at time of first dose of trial treatment.
• •Has a known history of active TB (Bacillus Tuberculosis).
• •Hypersensitivity to nivolumab or ipilimumab or any of its excipients.
• •Has had prior anticancer therapy within 4 weeks of study Day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• •Has a known additional malignancy that is progressing or requires active treatment.
• •Has known history of, or any evidence of active, non-infectious pneumonitis.
• •Has an active infection requiring systemic therapy.
• •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
• •Has received a live vaccine within 30 days of planned start of study therapy.
• •Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.