Patient schedule amended, 13 week samples removed,

Admin Version number, page numbers, contact details ‘tidied’, Tim Elliott’s name 1 t added, the word ‘be’ inserted paragraph 7.2.2 Inclusion criteria ‘Responding or stable disease as defined by oncologist following chemotherapy for metastatic disease, as demonstrated on CT scan in comparison with pretreatment CT scan (RECIST), within 4 weeks of trial entry’ to ‘Responding or stable disease as defined by an oncologist within 4 weeks of trial entry. The stable disease is assessed on the basis of clinical judgment and review of radiological imaging’ Exclusion criteria Subject has clinically apparent/active autoimmune disease (prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave’s disease, active Hashimoto’s thyroiditis, multiple sclerosis, insulin dependent diabetes mellitus and rheumatoid arthritis). Note: subjects with non-insulin dependent diabetes mellitus can be included, as can subjects with controlled and rarely flaring rheumatoid disease and endstage insulin dependent diabetes mellitus controlled on insulin.” to “Subject has clinically active autoimmune disease (prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave’s disease, active Hashimoto’s thyroiditis, multiple sclerosis, new on-set insulin dependent diabetes mellitus and rheumatoid arthritis). Note: subjects can be included with controlled and rarely flaring rheumatoid disease, endstage/advanced insulin dependent diabetes mellitus controlled on insulin, and burnt out/previously treated (e.g. radioactive iodine, thyroidectomy) autoimmune thyroid disease now stable on replacement therapy.” PIS The PIS has also been updated to reflect the changes in visits for bloods which was in the last amendment but was not updated at the time - the PIS now reflects the protocol and also Consent Form, page 8 Version number (point one) has been updated.