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

Brief summary public domain (ClinicalTrials.gov)

The purpose of this study is to investigate the effect of TG01 and Granulocyte macrophage colony stimulating factor (GM-CSF) when given in addition to gemcitabine (chemotherapy) and * Understand any possible side effects of the additional use of TG01/GM-CSF with gemcitabine * Investigate whether TG01/GM-CSF when given with gemcitabine can produce an immune response * Investigate if the treatment can delay or reduce recurrence of the disease

Intervention public domain (ClinicalTrials.gov)

Biological: TG01. TG01 and GM-CSF will be administered on days 1, 8, 15, 22 and 36. TG01 alone will also be given on days 36 and 50 for DTH assessment. Gemcitabine will start at least 3 weeks after TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total. Once chemotherapy is completed, GM-CSF and TG01 injections will resume and will be given every 4 weeks from the end of the chemotherapy period up to week 52 (plus once at week 5 post-chemotherapy) and then every 12 weeks from week 52 to week 104. TG01 alone will be given 8 weeks after the end of chemotherapy for DTH assessment. TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections. Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes

Intervention public domain (ClinicalTrials.gov)

Biological: TG01. For patients not able to start TG01 quickly after surgery, the vaccination can start at the same time as the chemotherapy as long as they start within 12 weeks from surgery. Gemcitabine will start at the same time as TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total. TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections. Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes

Arm public domain (ClinicalTrials.gov)

TG01/GM-CSF and Gemcitabine (experimental):

Primary outcome public domain (ClinicalTrials.gov)

Patients' Safety During Study. Assess the safety (number and nature of Adverse events and laboratory data occurring during study (before, during and after chemotherapy is given) in subjects treated with the Pancreatic Cancer ASCI Time frame: 2 years.

Primary outcome public domain (ClinicalTrials.gov)

Patients' Immune Response. Assess the Immune response (DTH responses and Proliferative T-cell responses) up to 2 years of treatment Time frame: During the 2 years of treatment.

Secondary outcome public domain (ClinicalTrials.gov)

Clinical Efficacy. Time frame: DFS was followed for up to 2 years and OS until last patient included had been in the study for 3 years..

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas 2. Stage I or II disease (clinical stage T1-3, N0-1, M0 by AJCC staging criteria). 3. Successful surgical resection * Complete resection (R0) or with microscopic residual disease (R1) * Expected to receive gemcitabine monotherapy as adjuvant chemotherapy 4. 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 5. 18 years of age or older. 6. ECOG performance status (PS) of 0-1. 7. Life expectancy of at least 6 months 8. Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy 9. Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures Exclusion Criteria: 1. Has received an investigational drug within 4 weeks prior to Trial drug administration 2. Has received previous therapy for pancreatic cancer including radiation or chemotherapy (except for the primary resection or primary neoadjuvant chemotherapy). 3. 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). 4. 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 5. Known history of positive tests for HIV/AIDS, hepatitis B or C 6. 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). 7. Contraindication to gemcitabine treatment 8. Have had any other malignancies within last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer) 9. Known malignant brain lesion(s) 10. Are unlikely to start chemotherapy within 12 weeks of surgery (e.g. delayed wound healing, or infection, etc.) 11. Are not expected to complete 6 cycles of chemotherapy 12. Are planned to receive …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 32 participants (actual).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Patients' Safety During Study [2 years]. Number, Events related to TG01 and /or GM-CSF. AEs related to TG01 and/or GM-CSF: TG01/GM-CSF and Gemcitabine (n=32): 90. SAEs related to TG01 and/or GM-CSF: TG01/GM-CSF and Gemcitabine (n=32): 2.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Patients' Immune Response [During the 2 years of treatment]. Number, percentage of patients. TG01/GM-CSF and Gemcitabine (n=32): 94.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Clinical Efficacy [DFS was followed for up to 2 years and OS until last patient included had been in the study for 3 years.]. Median, Months (Full Range). Overall survival: TG01/GM-CSF and Gemcitabine (n=32): 33.3 (24.0 to 40.0). Disease free survival: TG01/GM-CSF and Gemcitabine (n=32): 16.1 (11.1 to 19.6).