Adverse events should be followed up. All patients who have new or worsening Common Toxicity Criteria (CTC version 4) grade 3 or 4 laboratory values at the time of discontinuation must have further laboratory tests performed and the results recorded on the appropriate CRF until the laboratory values have returned to CTC grade 1 or 2, unless these values are not likely to improve because of the underlying disease. In these cases, the investigators must record their opinions on the CRFs and in the patient’s medical records. Laboratory abnormalities should not be reported as adverse events unless any criterion for an AE is fulfilled i.e. that it is clinically significant and because it is detrimental to the patient , the laboratory abnormality causes study drug dose adjustment , leads to patient ’s discontinuation from the study, or the investigator insists the abnormality s hould be reported as an AE. Laboratory abnormalities should not be reported as separate adverse events if they are part of an overall diagnosis (e.g. fever and leucocytosis for pneumonia). At discontinuation all on -going study- related toxicities and SAEs must be followed until resolution, unless in the investigator’s opinion, the condition is unlikely to resolve due to the patient’s underlying disease. CT TG01 -01 Version v 10.0 27 June 2018 Confidential 51 / 87 After discontinuation from treatment, patients must be followed up for all existing and new AEs for 28 calendar days after the last dose of study drug. All new AEs occurring during that period must be recorded (if SAEs they must be reported to ICON Safety group within 24 hours (Fax Number: +44 870 710 7157) and followed up for resolution as above. Life -threatening or fatal events occurring prior to document recurrence should be reported to the Medical Monitor by calling +44 203 291 3032 within 2 hours of knowledge of the event. Should protocolled dosing be stopped during the study, the principal investigator/sub - investigator will perform the best possible observation(s), test(s) and evaluation(s) as well as give appropriate medication and all possible measures for the safety of the patient. In addition, they will record on the CRF the date of discontinuation, the reasons, manifestation and treatment at the time of discontinuation and also course, treatment and outcome after discontinuation. They will also immediately inform the CRA of the discontinuation. Any SAE should be communicated to ICON Safety group according to the procedures defined in Section 7.3. 3.4 Time schedule Screening must be completed within the 56 days prior to the start of treatment for the main group and the modified vaccination group and within 84 days for the concomitant group. Patients will be required to attend the clinic for the administration and evaluation of their therapy (See Section 3.1). For each administration of study drug, patients will be observed for at least 30 minutes after each injection of TG01. Hospitalisation for administrative reasons will be at the investigator’s discretion, in accordance with hospital standard procedures and will not be considered as a serious adverse event. Safet y will be monitored for each patient throughout the trial until their end of study visit which will be 28 days after their last GM -CSF/TG01 or chemotherapy dose, whichever is appropriate. For all patients, where possible, a survival follow-up will be performed every 6 months after the initial 2 years of study period and until the last remaining patient in the modified cohort reaches the 2 years study period or withdraws consent or experiences toxicity, whichever is the earliest . Thereafter, a survival follow -up will continue to be performed approximately every 12 months until end of life.