In this event, the reasons for withdrawal will be documented. • Unacceptable adverse event(s) as described in Section 3.1.1 (Definition of Dose- Limiting Toxicity); or there is evidence of any ≥ grade 2 allergic and ≥ grade 2 autoimmune reaction(s) attributed to vaccine ( except grade 2 endocrine- related immune toxicity or grade 3 endocrine- related immune toxicit y that resolv es to grade ≤ 1 clinically within 7 days of initiating supportive therapy); or i f > grade 2 toxicity attributed to vaccine persists for > 28 days, the patient will not receive further vaccine inoculations and will be removed from protocol therapy . Patients who come off treatment must be followed on study until resolution of toxicity and until disease progression.