Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer

Korábbi kezelés

• Received any anti-pancreatic cancer therapy (symptomatic therapies are allowed), or any prior anti-cancer immunotherapy.
• Systemic steroid therapy (> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.
• Prior allogeneic stem cell transplantation or organ transplantation.
• Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug.
• Received a live vaccine ≤ 28 days before first dose of study drug.
• Concurrent participation in another therapeutic clinical study

Más betegség

• Diagnosed with another cancer whose natural history or treatment could interfere with safety or efficacy assessments on this study.
• Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
• Active autoimmune disease.
• Active infection requiring systemic therapy.
• Known history of human immunodeficiency virus (HIV).
• Active or chronic hepatitis B or hepatitis C.
• Known active tuberculosis.
• History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases, chronic obstructive pulmonary disease (COPD), asthma requiring medication, etc.
• History of severe hypersensitivity reaction to any monoclonal antibody

Egyéb

• Pregnant or breastfeeding

• Have a newly diagnosed, biopsy-proven adenocarcinoma of the pancreas.
• Tumor must be deemed resectable by the study team
• Patient's acceptance to have a tumor biopsy.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
• Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
• For both Women and Men, must use acceptable form of birth control while on study.