brain MRI, bone scan. Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 31 STUDY ASSESSMENT CALENDAR AssessmentsScreening (Prior to Part Two registration) Baseline (Prior to first vaccine) On-Study/Course of Treatment (1 vaccine = 1 cycle)1 Post-Treatment Follow-up Within 3 MonthsWithin 4 WeeksWithin 7 DaysWithin 7 DaysWithin 2 DaysDay 0Day 14 (±5 d)Day 28 (±5 d)Day 42 (±5 d)Day 562 (±5 d)Subsequent Follow-up Visits3 Confirmation of diagnosis by NCI Lab of Pathology4 X Medical history5 X Physical exam X X X X X X X X Performance status (ECOG)6 X X X X X X X Weight X X X X X X X Vital signs7 X X X X X X X X ȕ-HCG pregnancy test8 X X X X X X X9 Urinalysis10 X X EKG X Toxicity assessment11 X12 X X X X X Serology 1 Assessments must be performed within 2 days prior to each vaccination on Days 14, 28, & 42. Patients may receive a 2nd course of treatment for a total of 8 cycles. 2 If a patient receives a second course of four vaccines, the first follow-up evaluation will be two weeks (± 5 days) after the eighth vaccination. 3 All patients will return to the NIH Clinical Center for their second follow-up evaluation one month (± 5 days) after the firs t follow-up evaluation. Subsequent follow- up evaluations will take place every 1-2 months for the first year, and then annually for up to five years or until clinically proven progressive disease, whichever comes first. Patients may be seen more frequently as clinically indicated. Patients who are unable or unwilling to return for follow- up evaluations may be followed via phone or email contact. Patients may be asked to send laboratory, imaging, and physician exam reports performed by their treating phy sician. 4 Confirmation of diagnosis of metastatic melanoma, gastrointestinal, or genitourinary cancer. Testing is permitted to be condu cted at any time prior to Part Two registration. 5 Patient history may be obtained within 8 weeks prior to Part Two registration. 6 ECOG of 0 or 1 (see Appendix B ). 7 After each vaccination, vital signs will be monitored hourly (± 15 minutes) for two hours. The post-administration monitoring period may be adjusted by the PI. 8 Serum or urine; on all women of child-bearing potential. 9 Complete at all follow-up evaluations within 120 days after the last vaccine. 10 With culture if indicated. 11 Including a review of systems.