M7824 (MSB0011359C) in Combination With Gemcitabine in Adults With Previously Treated Advanced Adenocarcinoma of the Pancreas

Exclusion Criteria

• •Patients must have disease that is not amenable to potentially curative resection.
• •Subjects must have progressed on or after standard first-line systemic chemotherapy.
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• •Must have evaluable or measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1.
• •Adequate hematological function defined by:
• •* white blood cell (WBC) count greater than or equal to 3x10(9)/L
• •* with absolute neutrophil count (ANC) greater than or equal to 1.5x10(9)/L
• •* lymphocyte count greater than or equal to 0.5x10(9)/L,
• •* platelet count greater than or equal to 120x10(9)/L, and
• •* Hemoglobin (Hgb) greater than or equal to 9 g/dL (in absence of blood transfusion)
• •Adequate hepatic function defined by:
• •* a total bilirubin level less than or equal to 1.5xUpper limit of normal (ULN),
• •* an aspartate aminotransferase (AST) level less than or equal to 2.5xULN,
• •* alanine aminotransferase (ALT) level less than or equal to 2.5Xuln.
• •Adequate renal function defined by:
• •* Creatinine up to 1.5 upper institutional limits OR creatinine clearance (CrCl) \>50 mL/min/1.73 m\^2 OR within normal as predicted by the Cockcroft-Gault formula:
• •Creatinine Clearance (CrCl)=(140-age) x (weight in kg) x (0.85, if female)/72 x Serum Creatinine (mg/dL)
• •\- The effects of the study treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) within 28 days prior to study entry, for the duration of study participation and up to 120 days after the last dose of the drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• •Patients who are receiving any other investigational agents
• •Prior therapy with any antibody / drug targeting T cell coregulatory proteins (immune checkpoints) such as anti-Programmed cell death protein 1 (PD-1), anti-Programmed death-ligand 1 (PD-L1), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody.
• •Anticancer treatment within designated period before enrollment including:
• •* minor surgical procedure (such as biliary stenting) within 14 days
• •* major surgical procedure or radiation treatment within 28 days
• •* chemotherapy or experimental drug treatment with published half-life known to be 72 hours within 14 days
• •* experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days
• •* radiotherapy for measurable lesions delivered in a normal organ-sparing technique within 21 days (except for palliative radiotherapy)
• •Concurrent treatment with non-permitted drugs including herbal remedies with immunostimulating properties (for example, mistletoe extract) or known to potentially interfere with major organ function (for example, hypericin).
• •Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with a history of cervical carcinoma in situ, superficial or no-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded.
• •Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.
• •Receipt of any organ transplantation, including allogeneic stem-cell transplantation, except of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant)
• •Significant acute or chronic infections including tuberculosis (history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings)
• •Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent with the exceptions:
• •* diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;