Intratumoral MMR Vaccine Injection in Borderline Resectable/Unresectable Pancreatic Cancer

Prior treatment

• Subject must not have received any live vaccine, including MMR, within 30 days prior to the dose of study drug.
• Subject must not have treatment with any anti-cancer therapy including chemotherapy, radiotherapy, biological, immunotherapy or an investigational therapy, including targeted small molecule agents, within 5 half-lives (or 2 weeks if half-life is unknown) prior to day 1.
• Subject has no unresolved toxicities, AEs ≥ Grade 2 (NCI CTCAE version 5.0), from prior anticancer therapy.

Other illness

• Pancreatic cancer that was either resectable before SoC treatment or became resectable following SoC chemotherapy and RT.
• Subjects with radiographically proven metastatic disease are excluded.
• Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.

Other

• Subject must not be pregnant and/or currently breastfeeding or plan to be.

• Age ≥ 18 years.
• Pathologically proven locally advanced adenocarcinoma of pancreas.
• Borderline resectable pancreatic cancer that is determined to be unresectable following completion of SoC chemotherapy and RT as evidenced by any of the following:
  • Encasement of gastroduodenal artery up to the common hepatic artery/short segment encasement or abutment of the hepatic artery, but without extension to the celiac trunk.
  • Venous involvement of SMV or portal vein, less than 180 degrees.
  • Tumor abutment of SMA, less than half the circumference of the vessel wall. OR
  • Unresectable pancreatic cancer that remains unresectable following completion of SoC chemotherapy and RT as evidenced by any of the following:
  • Greater than 180-degree encasement or occlusion/thrombus of SMA, unresectable SMV, or SMV-portal confluence occlusion.
  • Direct involvement of inferior vena cava, aorta, celiac trunk, or hepatic artery, as defined by the absence of fat plane between low-density tumor and these structures on CT scan.
  • OR Surgeon deems that the pancreatic cancer is unresectable.
• Prior history of treatment with chemotherapy (e.g., FOLFIRINOX, Gemcitabine + Abraxane or NALIRIFOX \[liposomal irinotecan (Nal-IRI or Onivyde®), Nab Paclitaxel, 5 fluorouracil (5-FU)/leucovorin and oxaliplatin\]) and RT. The chemotherapy regimen is per treating physician's choice. The chemotherapy agent for radio sensitization is up to the treating physician (capecitabine, 5FU or gemcitabine).
  • The chemo-radiation therapy regimen should be completed at least 6 weeks but no more than 12 weeks from planned Day 1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Adequate hematological function (Hemoglobin \> 9g/dL, White Blood Cell (WBC) count \> 1500 K/µL, Absolute Neutrophil Count (ANC) \> 500 K/µL, Platelet count \> 100 K/µL).
• Adequate hepatic function (Total bilirubin ≤ 1.5 x institutional upper limit of normal \[ULN\]) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \>1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 × ULN, subject is eligible); Aspartate aminotransferase (AST\[SGOT\]) or Alanine aminotransferase (ALT\[SGPT\]) ≤ 2.5 × institutional ULN; Serum albumin ≥ 3.0 g/dL.
• Adequate renal function (i.e., creatinine less than 1.5 times ULN).