Do not make unauthorized copies. 5. A complete blood count (CBC) with differential and platelet count must be performed. (HIV and hepatitis testing is not required if the subject has no medical history of HIV). 6. Routine pre-operative serum chemistries (including, but not limited to creatinine, total bilirubin, alkaline phosphatase, and aspartate transaminase (AST) and/or alanine transaminase (ALT). 7. Blood collection for immune function analysis will be obtained at tissue harvest. (≤1 week of tissue procurement) 8. Plasma collection for immune function analysis (ctDNA) (≤1 week of tissue procurement) Screening Assessments / Protocol Screening The following evaluations will be performed on all subjects within 2 weeks of Cycle 1 (unless otherwise specified): 1. A signed protocol specific Informed Consent Form must be obtained. 2. It has been confirmed that the subject meets all inclusion criteria and none of the exclusion criteria. 3. A physical examination (including vital signs, height, temperature and body weight) must be obtained. 4. Ass essment of concomitant medications 5. Assessment of PS on the Karnofsky or Lansky scale (see Appendix A) must be obtained. 6. Radiological assessment of disease status with computed tomography (CT) chest /abdomen/pelvis (magnetic resonance imaging (MRI) abd/pelvis may be substituted for CT abd/pelvis) within 4 weeks of Cycle 1. The methods used for prestudy assessments (e.g., CT or MRI) should be used throughout the study. If possible, the same equipment should be used each time. Radiographic assessments must be from after the tissue harvest for vaccine manufacture to ensure true baseline disease status is captured. Images must be uploaded into WorldPro or submitted to WorldCare. 7. A complete blood count (CBC) with differential and platelet count must be performed. (HIV and hepatitis testing is not required if the subject has no medical history of HIV). 8. Serum chemistries (creatinine, glucose, total protein, blood urea nitrogen (BUN), total carbon dioxide (CO2), albumin, total bilirubin, alkaline phosphatase, and aspartate transaminase (AST) and/or alanine transaminase (ALT)) and electrolytes (total calcium, chloride, potassium, sodium) must be performed. 9. Blood collection for immune function analysis (ELISPOT). 10. Plasma collection for immune function analysis (ctDNA). 11. Pregnancy test for those of childbearing potential. 12. Submission to Gradalis, Inc. of preferably 20 unstained tumor slides or tissue block for correlative immunohistochemistry assay. These slides should correlate with tumor procured for vaccine manufacture. Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 51 of 74 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document. Do not make unauthorized copies. Assessments During Treatment The following evaluations will be performed on Day 1 of each cycle (1 Cycle = 21 days ±3 days) (unless otherwise specified): 1. *A physical examination, including vital signs and body weight. 2. *A toxicity assessment (CTCAE v 5). 3. *Assessment of concomitant medications. 4. Radiological assessment of disease status with CT chest /abd/pelvis (MRI abd/pelvis may be substituted for CT abd/pelvis) every 6 weeks ± 7 days from Cycle 1 regardless of treatment arm assignment or treatment delay. The methods used for prestudy assessments (e.g., CT or MRI) should be used throughout the study. If possible, the same equipment should be used each time. 5. *A CBC with differential and platelet count. 6. *Serum chemistries (creatinine, glucose, total protein, blood urea nitrogen (BUN), total carbon dioxide (CO2), albumin, total bilirubin, alkaline phosphatase, and aspartate transaminase (AST) and/or alanine transaminase (ALT)) and electrolytes (total calcium, chloride, potassium, sodium). 7. Blood collection for immune function analysis (ELISPOT) on Day 1 (prior to chemotherapy administration) at Cycles 2, 4, and 6. 8. Plasma collection for immune function analysis (ctDNA) on Day 1 prior to chemotherapy administration at Cycles 2, 3, 4 and 6. 9. *Assessment of Karnofsky Performance Status or LS . 10. Group A and B participants: oral temozolomide 100 mg/m 2 daily (Days 1 – 5, total dose 500 mg/m2/cycle) 11. Group A and B participants: oral irinotecan 50 mg/m2 daily (Days 1 – 5, total dose 250mg/m2/cycle) 12. Group A participants: Vigil 1.0 x 106 cells/injection, intradermally on Day 15. 13. Cross -over Subjects: Vigil 1.0 x 106 cells/injection, intradermally every 21 days 14. For those randomized to Group A or in cross -over, Vigil administration. Day 16 post Vigil administration assessment of injection site. Instruct the subject on Day 15 to observe the injection site 24 hours after the product administration. (This may be conducted at home). Have the subject follow up with the clinic if an injection site reaction is present. Please note if the subject reports of any redness, swelling or other response. If the subject identifies any redness, and /or swelling, please ask the subject if it is feasible to take a photograph of the injection site. If photographing the injection site is possible, please instruct the subject to place a measuring tool (bulk supplies provided to the site) next to the injection site reaction in the picture, if feasible. The photograph may be provided to the clinic upon the next visit as a hard copy or electronic jpg image. Please instruct the participant to avoid capturing images that would identify the subject (i.e. face and head). 15. Submission of Next Generation Sequencing data, if available in medical records. Subjects who are stable at the end of Cycle 4, with prior approval by the Sponsor may conduct evaluations denoted with an asterisk* on Day 15 of each cycle (1 Cycle = 21 days ±3 days) (unless otherwise specified). Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 52 of 74 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document. Do not make unauthorized copies. Subjects who become child-bearing while on study will have a pregnancy test performed prior to their next dose. See Section 8.6. End of Treatment Assessment s The following evaluations will be performed within 30 days after completion of the study regimen and / or within 30 days of disease progression (whichever event occurs first) (unless otherwise specified): 1. A physical examination, including vital signs and body weight. 2. Toxicity assessment (adverse events). 3. Assessment of concomitant medications taken. 4. Assessment of Karnofsky Performance Status/Lansky Performance Status 5. Radiological assessment of disease status with CT chest /abd/pelvis (MRI abd/pelvis may be substituted for CT abd/pelvis) within 45 days of the last injection or disease recurrence or progression 6. A CBC with differential and platelet count. 7. Serum chemistries (creatinine, glucose, total protein, blood urea nitrogen (BUN), total carbon dioxide (CO2), albumin, total bilirubin, alkaline phosphatase, and aspartate transaminase (AST) and/or alanine transaminase (ALT)) and electrolytes (total calcium, chloride, potassium, sodium). 8. Blood (PBMC) for immune function analysis (ELISPOT). 9. Plasma for immune function analysis (ctDNA). Response Follow Up Assessments If the study agent is discontinued (for reasons such as completion of all available doses of vaccine, intolerable toxicity, treatment interruption of more than 4 weeks, intercurrent illness, protocol deviation, at PI’s discretion), the subject will be followed quarterly after the end of study visit until progression. The following evaluations will be performed quarterly (every 3 months ±7 days) (unless otherwise specified): 1. A physical examination, including vital signs and body weight. 2. Assessment of concomitant medications taken. 3. Radiological assessment of disease status with CT chest /abd/pelvis (MRI abd/pelvis may be substituted for CT abd/pelvis) must be collected. The methods used for prestudy assessments (e.g., CT or MRI) should be used throughout the study. If possible, the same equipment should be used each time. 4. A CBC with differential and platelet count. Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 53 of 74 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document.