Access to stored clinical samples is restricted. Samples will be stored until requested by a researcher named on the protoc ol. All requests are monitored and tracked in LABrador. All researchers are required to sign a form stating that the samples are only to be used for research purposes associated with this trial (as per the NIH Intramural IRB-approved protocol) and that any unused samples must be returned to the BPC. It is the responsibility of the NCI Principal Investigator (PI) to ensure that the samples requested are being used in a manner consistent with NIH Intramural IRB approval. Following completion of this study, samples will remain in storage as de tailed above. Access to these samples will only be granted following NIH Intramural IRB approval of an additional protocol, granting the rights to use the material. If, at any time, a patient withdraws from the study and does not wish for their existing samples to be utilized, the individual must provide a written request. Following receipt of this request, the samples will be destroyed and reported as such to the NIH-IRB. Any samples lost (in transit or by a researcher) or destroyed due to unknown sample integrity (i.e. broken freezer allows for extensive sample thawing, etc.) will be reported as such to the NIH Intramural IRB. Sample barcodes are linked to patient demographics and limited clinical information. This information will only be provided to investigators listed on this protocol, via registered use of the LABrador. It is critical that the sample remains linked to patient information such as race, age, dates of diagnosis and death, and histological info rmation about the tumor, in order to correlate genotype with these variables. Blood and tissue collected during the course of this study will be stored, tr acked, and disposed of as specified in protocol 03-C-0277. 6 DATA COLLECTION AND EVALUATION DATA COLLECTION The PI will be responsible for overseeing entry of data into an in-house password-protected electronic system (C3D) and ensuring data accuracy, consistency and timeliness. The PI, associate investigators (AI), research nurses, and/or a contracted data manager will assist with the data management effo rts. All data obtained during the conduc t of the protocol will be kept in secure network drives or in appr oved alternative sites that comply with NIH security standards. Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 38Primary and final analyzed data will have identifiers so that research data can be attributed to an individual human subject participant. Data will be entered into the NCI CCR C3D database. All AEs, including clinically significant abnor mal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. Patients will be followed for AEs from the time the patient receive s the first mRNA vaccine dose to the time of the second follow-up evaluation, or until off-study, whichever comes first. An abnormal laboratory value will be re corded in the database as an AE only if the laboratory abnormality is characterized by any of the following: x Results in discontinuation from the study x Is associated with clinical signs or symptoms x Requires treatment or any other therapeutic intervention x Is associated with death or another serious adverse event, including hospitalization x Is judged by the investigator to be of significant clinical impact x If any abnormal laboratory result is considered clinically significant, the investigator will provide details about the action taken with respect to the test drug and about the patient’s outcome. All AEs must be recorded on the AE case report form unless otherwise noted below in Section 6.1.1. End of study procedures: Data will be stored according to HHS and FDA regulations, and NIH Intramural Records Retenti on Schedule as applicable. Loss or destruction of data: Should we become aware that a major breach in our plan to protect subject confidentiality and trial data has occurred, the NIH Intramural IRB will be notified. 6.1.1 Exclusions to Routine Adverse Event Recording There are no exclusions to routine AE reporting/recording for this protocol. DATA SHARING PLANS 6.2.1 Human Data Sharing Plan Coded, linked human data generated for use in future and ongoing research will be shared through a NIH-funded or approved repository (Clin icalTrials.gov) and BTRIS. At the completion of data analysis, data will be submitted to ClinicalTrials.gov either before publication or at the time of publication or shortly ther eafter. Data may also be used to support long-term research efforts within the NCI-SB, and coded, linked data may also be shared with collaborators as specified in protocol 03-C-0277. 6.2.2 Genomic Data Sharing Plan The NIH Genomic Data Sharing Policy does not apply to this study. RESPONSE CRITERIA For the purposes of this study, patients should be re-evaluated for resp onse approximately two weeks following the last vaccination, then one month later x1, then every 1-2 months for the first Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 39 year, and then annually for up to five years or until clinically proven progressive disease, whichever comes first. In addition to a baseline scan, confirmatory scans should also be obtained at least 4 weeks (but not less than 4 weeks) following initial documentation of objective response. Response and progression will be ev aluated in this study using the new international criteria proposed by the revised Response Evaluation Cr iteria in Solid Tumors (RECIST) guideline (version 1.1) 28 Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST v1.1 criteria. 6.3.1 Disease Parameters Measurable disease: Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as: x By chest x-ray:  20 mm x By CT scan: o Scan slice thickness 5 mm or under:  10 mm o Scan slice thickness > 5 mm: double the slice thickness x With calipers on clinical exam:  10 mm All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). Malignant lymph nodes: To be c onsidered pathologically enlarged and measurable, a lymph node must be > 15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm). At base line and in follow-up, only the short axis will be measured and followed. Non-measurable disease: All othe r lesions (or sites of disease), including small lesions (longest diameter < PPRUSDWKRORJLFDOO\PSKQRGHVZLWK 10 to < 15 mm short axis), are considered non-measurable disease. Bone le sions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflamma tory breast disease, and abdominal masses (not followed by CT or MRI) are considered as non-measurable. Target lesions: All measurable lesions up to a ma ximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, shoul d be identified as target lesions and recorded and measured at baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter), be representative of all involved organs, but in addition should be those that lend themselves to reproducible repe ated measurements. It may be the case that, on occasion, the largest lesion does not lend itself to reproducible measurement in which circumstance the next largest lesion which can be measured reproducibly should be selected. A sum of the diameters (longest for non-nodal lesion s, short axis for nodal lesions) for all target lesions will be calculated and reported as the baseline sum di ameters. If lymph nodes are to be included in the sum, then only the short axis is added into the sum. The baseline sum diameters will be used as reference to further characterize any objective tumor regression in the measurable dimension of the disease. Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 40 Non-target lesions: All ot her lesions (or sites of disease) in cluding any measurable lesions over and above the 5 target lesions should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence, absence, or in rare cases unequivocal progression of each should be noted throughout follow-up. 6.3.2 Methods for Evaluation of Measurable Disease All measurements should be taken and recorded in metric notation using a ruler or calipers. All baseline evaluations should be performed as closely as possible to the beginning of treatment and never more than 4 weeks before the beginning of the treatment. The same method of assessment a nd the same technique should be used to characterize each identified and reported lesion at baseline a nd during follow-up. Imaging-based evaluation is preferred to evaluation by clin ical examination unless the lesi on(s) being followed cannot be imaged but are assessable by clinical exam. Clinical lesions: Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes) and  10 mm diameter as assessed using calipers (e.g., skin nodules). In the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion, is recommended. Conventional CT and MRI: This guideline has de fined measurability of lesions on CT scan based on the assumption that CT slice thickness is 5 mm or less. If CT scans have slice thickness greater than 5 mm, the minimum size for a measurable lesion should be twice the slice thickness. MRI is also acceptable in certain situations (e.g. for body scans). Ideally, the same type of scanner should be used and the image acquisition protocol should be followed as closely as possible to prior scans. Body scans should be pe rformed with breath-hold scanning techniques, if possible. FDG-PET: While FDG-PET response assessments need additional study, it is sometimes reasonable to incorporate the use of FDG-P ET scanning to complement CT scanning in assessment of progression (partic ularly possible ‘new’ disease) . New lesions on the basis of FDG-PET imaging can be identified according to the following algorithm: x Negative FDG-PET at baseline, with a positiv e FDG-PET at follow-up is a sign of PD based on a new lesion. x No FDG-PET at baseline and a positive FDG-PET at follow-up: If the positive FDG-PET at follow-up corresponds to a new site of disease confirmed by CT, this is PD. If the positive FDG-PET at follow-up is not confirmed as a new site of disease on CT, additional follow-up CT scans are needed to determine if there is truly progression occurring at that site (if so, the date of PD will be the date of the initial abnormal FDG-PET scan). If the positive FDG-PET at follow-up corresponds to a pre-existing site of disease on CT that is not progressing on the ba sis of the anatomic images, this is not PD. x FDG-PET may be used to upgrade a response to a CR in a manner similar to a biopsy in cases where a residual radiographic abnormalit y is thought to represent fibrosis or scarring. The use of FDG-PET in this circum stance should be prospectively described in the protocol and supported by disease-specif ic medical literature for the indication. However, it must be acknowledged that both approaches may lead to false positive CR due to limitations of FDG-PET and biopsy resolution/sensitivity. Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 41Note: A ‘positive’ FDG-PET scan lesion means one which is FDG avid with an uptake greater than twice that of the surrounding tissue on the attenuation corrected image. 6.3.3 Response Criteria Definitions Evaluation of Target Lesions Complete Response (CR): Disappearance of a ll target lesions. Any pathological lymph nodes (whether target or non-target) must ha ve reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of th e diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative incr ease of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progressions.) Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target le sions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis). (Note: If tumor markers are initially above the upper normal limit, they must normalize for a patient to be considered in complete clinical response.) Non-CR/Non-PD: Persistence of on e or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-targ et lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease st atus change, not a single lesion increase. Although a clear progression of “non-target” le sions only is exceptional, the opinion of the treating physician should prevail in such circum stances, and the progression status should be confirmed at a later time by the review panel (or PI). Evaluation of Best Overall Response The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both meas urement and confirmation criteria. For Patients with Measurable Disease (i.e., Target Disease) Target Lesions Non-Target Lesions New Lesions Overall Response Best Overall Response when Confirmation is Required* CR CR No CR 4 weeks confirmation** CR Non-CR/Non-PD No PR 4 weeks confirmation** Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 42 CR Not evaluated No PR PR Non-CR/Non- PD/Not evaluated No PR SD Non-CR/Non- PD/Not evaluated No SD Documented at least once 4 weeks from baseline** PD Any Yes or No PD No prior SD, PR, or CR Any PD*** Yes or No PD Any Any Yes PD * See RECIST v1.1 manuscript for further details on what is evidence of a new lesion. ** Only for non-randomized trials with response as primary endpoint.