22- to 28-gau ge). MVA-br achyury -TRICOM is to be administered via subcutaneous injection in the upper arm and/or outer thigh per the schedule described in Section 3.1.3. 3.3 S TUDY CALENDAR Baseline1 Day 1 Day 29 Day 57 Restaging Day 85 Day 169 and every 85 days thereafter until progression History and X 36 Abbreviated Title: Phase I MVA -Brachyury -TRICOM Version Date: September 14, 2016 Confidential physical1 Medical assessments2 X X8 X8 X8 X Imaging X3 X X Urinalysis X X X X X Serum HIV antibody4 X Serum hepatitis B & C5 X CBC with differential, platele t count X1 X X X X Chemistry6 X1 X X X X EKG X1 X X Correlative / Immunology (blood)10 X X X X X ANA titer X X X CD3, 4, 8, 19 subsets, NK markers and CD4:CD8 ratio X X X X HLA typing X Serum beta- HCG7 X Pulse oximetry X MVA -brachyury - TRICOM vaccine9 X X X Adverse events X X X X Concomitant medications X X X X X 1Baseline: H & P and laboratory studies should be completed within 16 days of initiating treatment. Baseline radiographic, EKG , and immunologic studie s should be obtained within 28 days of initiating treatment. 2 Medical assessments: interim history (since last visit), vital signs, physical examination and ECOG performance status. To be performed at baseline, within 3 days of each dose of vaccine and with each restaging visit (about every 85 days on study). 3 Radiologic studies consisting of CT chest/abdomen/pelvis (and MRI or bone scan when appropriate for tumor type) will be performed within 28 days prior to initiating treatment, on about day 85, and about every 85 days until progression. 4 Serum HIV antibody should be completed within 8 weeks of initiating treatment. 5Serum hepatitis B & C antibody should be completed within 8 weeks of initiating treatment. 6 Chemistry panel: Na+, K+, Cl –, CO 2, glucos e, BUN, creatinine, albumin, calcium, magnesium, phosphorus, alkaline phosphatase, ALT, AST, total bilirubin, TSH, and LDH. 7In females of child -bearing age, beta -HCG to be done at baseline within 48 hours prior to day 1.