Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer

Inclusion criteria

• Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
• Stage I or II disease (clinical stage T1-3, N0-1, M0 by AJCC staging criteria).
• Successful surgical resection

• Complete resection (R0) or with microscopic residual disease (R1)
• Expected to receive gemcitabine monotherapy as adjuvant chemotherapy
• Laboratory Values:

• Absolute neutrophil count ≥ 1.5 x 10^9/l
• Platelets ≥100 x 10^9/l
• Haemoglobin ≥ 9 g/dl
• Total bilirubin ≤ 1.5 x UNL
• Serum creatinine ≤ 1.5 x UNL
• Albumin ≥ 2.5 g/dl
• AST or ALT ≥ 5 x UNL
• 18 years of age or older.
• ECOG performance status (PS) of 0-1.
• Life expectancy of at least 6 months
• Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy
• Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures

Exclusion criteria

• Has received an investigational drug within 4 weeks prior to Trial drug administration
• Has received previous therapy for pancreatic cancer including radiation or chemotherapy (except for the primary resection or primary neoadjuvant chemotherapy).
• Is currently receiving any agent with a known effect on the immune system, unless at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg/day or less or as inhaled steroid at doses used for the treatment of asthma).
• Has any other serious illnesses or medical conditions such as, but not limited to:

• Any uncontrolled infection
• Uncontrolled cardiac failure classification III or IV (NY Heart Association)
• Uncontrolled systemic and gastro-intestinal inflammatory conditions
• Bone marrow dysplasia
• History of auto-immune disease
• History of adverse reactions to vaccines
• Known history of positive tests for HIV/AIDS, hepatitis B or C
• Pregnant or lactating females or have no pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential).
• Contraindication to gemcitabine treatment
• Have had any other malignancies within last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer)
• Known malignant brain lesion(s)
• Are unlikely to start chemotherapy within 12 weeks of surgery (e.g. delayed wound healing, or infection, etc.)
• Are not expected to complete 6 cycles of chemotherapy
• Are planned to receive yellow fever or other live (attenuated) vaccines during the course of study