The Miami "EMPIRE" Trial - Treating Metastatic Pancreatic Cancer with Immunotherapy and Radiation

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of pancreatic ductal adenocarcinoma.
• Disease must be microsatellite stable (MSS).
• Must have measurable cancer as defined by specific medical criteria.
• Cancer must have progressed after at least one line of systemic therapy.
• Cannot be receiving certain other treatments like IL-2, interferon, or other immunotherapies.
• Must not have HIV or active Hepatitis B infection.
• Must have a good performance status, meaning able to carry out daily activities with minimal symptoms.
• Must have a life expectancy of at least 3 months.
• Must meet specific blood test requirements, including:
  • Neutrophil count of at least 1,000 cells/μL
  • White blood cell count of at least 2,000 cells/μL
  • Platelet count of at least 75,000 per μL
  • Hemoglobin level of at least 8.0 g/dL
  • Kidney function with creatinine clearance of at least 40 mL/min
  • Liver function tests within specified limits
  • Blood clotting times within specified limits
  • Lymphocyte count of at least 1,000 cells/μL
• Must have at least one tumor that has not been treated with radiation and can be biopsied before treatment.
• Liver tumor burden must be 25% or less of total liver volume.
• Women of childbearing potential must have a negative pregnancy test and use effective contraception.
• Men and women of reproductive potential must use effective contraception or abstain from sexual activity during the study and for at least 6 months after the last dose of study drugs.

Exclusion Criteria

• Liver tumor burden greater than 25% of total liver volume.
• Active, untreated cancer spread to the brain or spinal cord.
• Active autoimmune disease or history of autoimmune disease requiring treatment in the past 2 years.
• Need for systemic treatment with corticosteroids or other immunosuppressive medications recently.
• Previous radiation or certain treatments directed to the liver.
• Significant fluid buildup in the abdomen or history of liver failure.
• Recent bowel obstruction or signs of bowel obstruction.
• Significant heart disease or recent heart attack or stroke.
• Prior organ transplant.
• Recent chemotherapy or targeted therapy.
• Ongoing side effects from previous cancer treatments.
• Another active cancer requiring treatment.
• History of lung inflammation not caused by infection.
• Active infection needing antibiotics.
• Recent live vaccine.
• Recent COVID-19 vaccine or booster within 7 days of starting treatment.
• Severe allergic reaction to monoclonal antibodies.
• Impaired decision-making ability.