Are not expected to complete 6 cycles of chemotherapy 12. Are planned to receive yellow fever o r other live (attenuated) vaccines during the cour se of study (see concomitant medication section ) Investigational Products and Mode of Administration: TG01 : provided as a lyophilised powder for reconstitution in sterile water for injection to be given via intrader mal injection. GM-CSF : provided as a l yophilised powder for reconstitution in sterile water for injection to be given via intradermal injection GM-CSF to be given 10-15 minutes before TG01 in the main group and concomitant group . In the modified vaccination group GM-CSF is to be given 15-20 minutes before TG01. Gemcitabine : provided as a lyoph ilised powder (vials of 200 mg and 1 g) for reconstitution in saline to be given via intravenous injection. To be reconstituted according to Prescribing Informatio n for gemcitabine Or Optional 5-FU and Leucovorin (in patients with ALT/AST >2.5 x ULN at time of chemotherapy start) : 5-FU and Leucovorin: To be administered according to the Prescribing Information for 5-FU and in accordance with the standard procedure of the institution. Treatment Descrip tion: GM-CSF/TG01 Patients will receive the first dose of GM-CSF/ TG01 as soon as feasible after surgery. Patients will receive TG01 at a dose of 0.70 mg/injection (individual peptides comprising 0.10 mg each) 10-15 m inutes (or 15- 20 minutes in the modifie d vaccination group ) after 30 μg GM -CSF at each time point as an intradermal injection into the back of the upper arm . Patients will be observed for at least 30 minutes after each injection of TG01 . CT TG01 -01 Version v10.0 27 June 2018 Confidential 16 / 87 Hospitalisation of patients for administrative reasons only will be at the investigator’s discretion and would not qualify as a serious adverse event . TG01 for DTH testing As a DTH skin reactivity test control patients will be given TG01 at a dose of 0.70 mg /injection ( individual peptides comprising 0.10 mg each) without GM-CSF as an intradermal injection into the lower area of the contralateral arm. When a DTH test is being performed the DTH TG01 injection will be given at least 30 min before the GM -CSF administration and the TG01 administration 10 - 15 minutes after GM- CSF (15-20 minutes in the modified vaccination group ). Chemotherapy At start of chemotherapy: • Patients who have AST or ALT ≤ 2. 5 x UNL will receive gemcitabine according to protocol • Patients who have AST o r ALT > 2. 5 x UNL may receive 5 -FU and continue vaccination with TG01 as per protocol (at the investigator’s discretion) Gemcitabine will be given as 1000 mg/m2 iv over 30 minutes on days 1, 8 and 15 of a four- week cycle for 6 cycles in total. Should 5- FU be given instead of gemcitabine, the recommended regimen is 500 mg/m2, bolus i.v on day 1 and 2 and leucovorin 60mg/m2 (or 100mg) on day 1 and 2 every 2 weeks of a four- week cycle for 6 cycles. When applicable, chemotherapy is to be given on the same day and after TG01 injection . In this respect, in the main group and concomitant group, patients will receive GM -CSF/ TG01 in combination with chemotherapy for 6 cycles of 4 weeks. Treatment schedule The first day of GM-CSF/TG01 treatment will be consider ed Day 1 for the Visits. Main group : Chemotherapy should start not less than 3 weeks after the start of GM-CSF/TG01 and if possible within 12 weeks from surgery. In the event that chemotherapy cannot be started patients should continue to be vaccinated. All these patients will follow the schedule of assessments defined in Table 1. GM- CSF/TG01 will be given on days 1, 3, 5, 8, 15, 22 and then every 2 weeks until the end of chemotherapy treatment . Concomitant group : Where vaccination cannot be started soon af ter surgery, it is permissible to start GM-CSF/TG01 at the same time as chemotherapy and patients will follow T able 2 schedule of assessments. GM-CSF/TG01 will be given on days 1, 3, 5, 8, 15, 22 and then every 2 weeks until the end of chemotherapy treatme nt. Modified vaccination group : Chemot herapy should start not less than 3 weeks after the start of GM- CSF/TG01. P atients will be given GM-CSF/TG01 on days 1, 8, 15, 22 and 36 then if chemotherapy hasn’t started, 4 -weekly until the start CT TG01 -01 Version v10.0 27 June 2018 Confidential 17 / 87 of chemotherapy at which point vaccination will be put on hold until the end of chemotherapy treatment . Vaccination will resume after end of chemotherapy treatment (Table 3). All groups : In the case of early termination of chemotherapy treatment (prior to completion of 6 c ycles) , GM-CSF/TG01 will be continued a s per the treatment schedule. Main group and concomitant group: After the end of chemotherapy treatment for all patients who are recurrence- free (with or without a positive immune response) , further booster injections will be given every 4 weeks until 52 weeks, then every 12 weeks until 2 years or until withdrawal of consent or toxicity whichever is the earliest . Patients who recur and have a positive immune response during the study treatment period should continue to receive GM - CSF/TG01 every 4 weeks until 52 weeks, then every 12 weeks until 2 years or until withdrawal of consent or toxicity whichever is the earliest. From 26 January 2015 onward, f or all these subsequent GM-CSF/ TG01 administrations the patients sho uld be given prophylactic treatment (30 minutes before treatment) to prevent possible occurrence of allergic reacti ons. P atients who recur and do not have a positive immune response during the study treatment period w ill be withdrawn from the study.