Study on INCMGA00012 for Patients with Advanced Pancreatic or Ampullary Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of adenosquamous carcinoma of the pancreas or ampulla.
• The cancer must be advanced, meaning it cannot be surgically removed or has spread to other areas.
• Have received at least one prior chemotherapy treatment but no more than two, or be unable to tolerate or ineligible for such treatments.
• Have at least one tumor that can be measured.
• Agree to have a tumor biopsy before and during the treatment.
• Be in good general health with an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
• If HIV-positive, must have a CD4+ count of at least 350/μL, an undetectable viral load, and be on antiretroviral therapy.
• Have a life expectancy of more than 3 months.
• Have adequate organ and bone marrow function as shown by specific lab tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
• Men must agree to use birth control during the study.
• Must understand and agree to sign a consent form.

Exclusion Criteria

• Have a history or evidence of cancer spread to the brain.
• Have had recent chemotherapy, radiation, or biological therapy within 14 days before starting the study drug.
• Have used an investigational drug or device within 28 days before starting the study drug.
• Need any other cancer treatment while on the study.
• Have had major surgery within 28 days before starting the study drug, except for minor procedures.
• Have received a live vaccine within 28 days before starting the study drug.
• Have previously been treated with certain immunotherapy drugs.
• Have used systemic steroids within 14 days before starting the study.
• Have allergies to monoclonal antibodies.
• Have fluid buildup in the abdomen or around the lungs that is significant or cancerous.
• Have uncontrolled illnesses, such as infections, heart failure, unstable chest pain, or psychiatric conditions that would interfere with the study.
• Have a history of autoimmune disease requiring treatment in the last 2 years.
• Have any organ transplant, including corneal transplants.
• Have unresolved side effects from previous cancer treatments, except for hair loss and fatigue.
• Have hepatitis A, B, or C infections.
• Have low oxygen levels in the blood or need home oxygen.
• Have unhealed wounds or fractures.
• Have significant heart disease.
• Use illicit drugs or have substance abuse issues.
• Are unable or unwilling to follow the study schedule.
• Have a history of lung inflammation not caused by infection.
• Have low serum albumin levels.