Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal Carcinoma

Exclusion Criteria

• •1. Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment.
• •2. Receipt of any investigational anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
• •3. Major surgical procedure within 21 days prior to the first dose of IP.
• •4. Patients weighing less than 30 kg
• •5. History of leptomeningeal carcinomatosis
• •6. Ascites requiring intervention
• •7. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy
• •8. Current or prior use of immunosuppressive medication within 14 days of first dose
• •9. Brain metastases or spinal cord compression.
• •10. Medi4736+AZD5069 Cohort only: received any potent and moderate cytochrome CYP3A4 inhibitors, potent and moderate CYP3A4 inducers, P-gp substrates, BCRP substrates, sensitive CYP2B6 substrates, warfarin and coumarin derivatives, or herbal supplements within 14 days of the first dose of study treatment
• •11. Uncontrolled intercurrent illness
• •12. Other malignancy within 5 years except for noninvasive malignancies
• •13. Mean QT interval ≥470 ms
• •14. Active infection
• •15. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP
• •16. Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not employing an effective method of birth control
• •17. Prior exposure to immune-mediated therapy
• •18. Known allergy or hypersensitivity to IP formulations or to other human monoclonal antibodies