16 Research samples, as described in Section 5.3. 17 Imaging evaluation to determine baseline disease status. 18 Repeat imaging if not performed within 4 weeks of Day 0. 19 As performed at baseline to determine tumor response. If clinically indicated, other scans or x-rays may be performed, e.g., brain MRI, bone scan. 20 Administered intramuscularly. Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 33 CRITERIA FOR REMOVAL FROM PROTOCOL THERAPY AND OFF-STUDY CRITERIA Prior to removal from study, effort must be made to have all subjects complete an evaluation safety visit approximate ly 30 days following the first follow-up evaluation (at the second follow- up evaluation). 3.8.1 Criteria for Removal from Protocol Therapy Patients will be taken off treatment for the following: x Completion of second follow-up evaluation x Grade 3 or 4 toxicity due to the vaccine, excluding those known events such as local injection site reactions, skin rash, pruritus, fatigue, fever and local adenopathy. x Progression of disease x Patient requests to be withdrawn from protocol therapy x Investigator discretion x Positive pregnancy test 3.8.2 Off-Study Criteria Patients will be taken off-study for the following: x Vaccine does not meet CoA requirements x Completion of study follow-up period x Progression of disease x Patients begins a new therapy for their cancer x Patient requests to be w ithdrawn from the study x Significant noncompliance x Investigator discretion x Patient lost to follow-up x Patients who require the use of an y medications listed in Section 4 for clinical management. x Death All patients will be co -enrolled on protocol 09-C-0161. Patients who are taken off-study for progressive disease or study closure on the trea tment protocol will be followed on protocol 09-C- 0161.Once a subject is taken off-study, no further data can be collected on this treatment protocol. 3.8.3 Off Protocol Therapy and Off-Study Procedure Authorized staff must notify the NCI-CRO when a subject is taken off protocol therapy and when a subject is taken off-study. A Partic ipant Status Update Form from the website Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 34 (http://home.ccr.cancer.gov/intra/eligibility/welcome.htm) main page must be completed and sent via encrypted email to the NCI-CRO at ncicentralregist ration-l@mail.nih.gov. 4 CONCOMITANT MEDICATIONS/MEASURES Use of all medications taken at any time from consent to the last safety follow-up visit must be recorded in the subject’s electronic case report form (eCRF).