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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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
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
Oslo University Hospital HF the Norwegian Radium Hospital
Oslo, Norway
Centro Integral Oncologico Clara Campal / Hospital HM Universitario Sanchinarro
Madrid, Spain
Queen Elizabeth University Hospital / Edgaston /
Birmingham, United Kingdom
University of Liverpool / Molecular and Clinical Cancer Medicine
Liverpool, United Kingdom
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
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
Clinical Efficacy
Efficacy exploring disease free survival and overall survival.
Time frame: DFS was followed for up to 2 years and OS until last patient included had been in the study for 3 years.
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University of Manchester / The Christie NHS Foundation Trust
Manchester, United Kingdom