[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634397":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":30,"studyPopulation":26,"armGroups":31,"interventions":37,"overallOfficials":42,"centralContacts":46,"locations":26,"responsibleParty":57,"collaborators":26,"id":59,"slug":26,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":26},{"fullName":5,"class":6},"University of Arkansas","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Intratumoral T-Cell Response","Intratumoral T-cell Response (iTCR) will be defined as a change of greater than 2-fold increase in the frequency of IFNγ-positive T- cells in the repeat (4 week) tumor biopsy relative to the first (baseline) tumor biopsy. Each subject will be scored Yes or No for if they achieved iTCR. Subjects that decline the repeat tumor biopsy will be scored Not Evaluable (NE) for iTCR.","Baseline to 4 weeks post injection",[14],{"measure":15,"description":16,"timeFrame":17},"The clinical efficacy of MMR vaccines will be assessed according to RECIST 1.1","A subject's Progression Free Survival (PFS) will be defined as the time in months from the date when their tumor is injected with MMR vaccine to the date on which they either die or experience documented progressive disease (whichever occurs first). Subjects that are alive and progression-free on their date of at last contact will be right-censored for PFS.\n\nA subject's Overall Survival will be defined as the time in months from the date when their tumor is injected with MMR vaccine to the date on which they die. Subjects that are still alive at last contact will be right censored for OS.","At screening and every 12 weeks from day 1 for 2 years",[19],{"measure":20,"description":21,"timeFrame":22},"Immune response dynamics following treatment with MMR","T cell function will be at screening, Day 1, Day 8, Week 4 and Week 8 using PBMCs isolated from subject samples. Functional assays will include flow cytometry to assess T cell subsets including CD4 and CD8 T cells along with activation markers like CD69 and CD25. Markers of T cell exhaustion such as PD1, CTLA4, LAG3, VISTA and TIM3 will be analyzed to assess immune dysfunction and potential resistance to treatment. Intracellular cytokine staining will measure IFN gamma TNF alpha and IL2 production as indicators of immune response. ELISPOT assays will quantify antigen specific T cell responses while proliferation assays using CFSE dilution will evaluate T cell expansion. RNA sequencing and multiplex cytokine profiling will help characterize transcriptional and secretory profiles related to T cell activation exhaustion and memory formation. The FNA samples will used to study gene signatures","From MMR injection to week 8",{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":26,"timePerspective":26,"maskingInfo":28},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":29,"maskingDescription":26,"whoMasked":26},"NONE","This is a prospective single-arm phase Ib\u002FII study for subjects with locally advanced, borderline resectable \u002F unresectable, non-metastatic pancreatic cancer that remains unresectable following SoC chemotherapy and RT. Patients whose tumors have not become resectable following SoC treatment with chemotherapy and RT will be treated with intratumoral injection of MMR vaccine by endoscopy and endoscopic ultrasound. Patients with unresectable or borderline resectable pancreatic cancer treated via SoC protocol with induction chemotherapy (of physician's choice, e.g., FOLFIRINOX, Gemcitabine + Abraxane, Nab Paclitaxel or NALIRIFOX) followed by radiation (physician's preference) along with chemotherapy (5FU\u002Fcapecitabine, per physician's choice) will be eligible for the study if the tumor did not become resectable following the therapy just described.",[32],{"label":33,"type":34,"description":26,"interventionNames":35},"Intratumoral MMR Injection","EXPERIMENTAL",[36],"Biological: Intratumoral MMR Injection",[38],{"type":39,"name":33,"description":40,"armGroupLabels":41,"otherNames":26},"BIOLOGICAL","A single dose (0.5 mililiter) of MMR vaccine will be injected under endoscopic ultrasound guidance in the GI laboratory at UAMS under sedation as prescribed by the interventional gastroenterologist.\n\nThe injection will be at least 6 weeks but no later than 12 weeks post completion of chemo-radiation therapy.",[33],[43],{"name":44,"affiliation":5,"role":45},"Rangaswamy Govindarajan, MD","PRINCIPAL_INVESTIGATOR",[47,53],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Joseph Holley, BS","CONTACT","501-214-2499","24579","JAHolley@uams.edu",{"name":54,"role":49,"phone":50,"phoneExt":55,"email":56},"Jennifer Faulkner, MS","24544","JLFaulkner@uams.edu",{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100634397",false,"NCT07539155","Intratumoral MMR Vaccine Injection in Borderline Resectable\u002FUnresectable Pancreatic Cancer","Phase 1b\u002F2 Study of Intratumoral MMR Vaccine Injection in Borderline Resectable\u002FUnresectable Pancreatic Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Pathologically proven locally advanced adenocarcinoma of pancreas.\n3. Borderline resectable pancreatic cancer that is determined to be unresectable following completion of SoC chemotherapy and RT as evidenced by any of the following:\n\n   1. Encasement of gastroduodenal artery up to the common hepatic artery\u002Fshort segment encasement or abutment of the hepatic artery, but without extension to the celiac trunk.\n   2. Venous involvement of SMV or portal vein, less than 180 degrees.\n   3. Tumor abutment of SMA, less than half the circumference of the vessel wall. OR\n\n      Unresectable pancreatic cancer that remains unresectable following completion of SoC chemotherapy and RT as evidenced by any of the following:\n   4. Greater than 180-degree encasement or occlusion\u002Fthrombus of SMA, unresectable SMV, or SMV-portal confluence occlusion.\n   5. 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.\n\n   OR Surgeon deems that the pancreatic cancer is unresectable.\n4. 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)\u002Fleucovorin 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).\n\n   a. The chemo-radiation therapy regimen should be completed at least 6 weeks but no more than 12 weeks from planned Day 1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n6. Adequate hematological function (Hemoglobin \\> 9g\u002FdL, White Blood Cell (WBC) count \\> 1500 K\u002FµL, Absolute Neutrophil Count (ANC) \\> 500 K\u002FµL, Platelet count \\> 100 K\u002FµL).\n7. 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\u002FdL.\n8. Adequate renal function (i.e., creatinine less than 1.5 times ULN).\n\nExclusion Criteria:\n\n1. Pancreatic cancer that was either resectable before SoC treatment or became resectable following SoC chemotherapy and RT.\n2. Subjects with radiographically proven metastatic disease are excluded.\n3. Subject must not be pregnant and\u002For currently breastfeeding or plan to be.\n4. Subject must not have received any live vaccine, including MMR, within 30 days prior to the dose of study drug.\n5. 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.\n6. Subject has no unresolved toxicities, AEs ≥ Grade 2 (NCI CTCAE version 5.0), from prior anticancer therapy.\n7. Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.","ALL","18 Years",{"count":68,"type":69},20,"ESTIMATED","INTERVENTIONAL",[72,73],"PHASE1","PHASE2","By doing this study, it is the hope to learn whether an injection of the measles, mumps, rubella (MMR) vaccine developed by Merck \\& Co. (Merck's M-M-R® II) into the tumor is safe and effective in making the tumor smaller.",[76,77],"Borderline Resectable\u002FUnresectable Pancreatic Cancer","Non Metastatic Pancreatic Cancer",[79,80,81,82,83],"MMR","Borderline Resectable","Borderline Unresectable","Pancreatic Cancer","Non-Metastatic","NOT_YET_RECRUITING","2026-06-09",{"date":87,"type":88},"2026-06-10","ACTUAL",{"date":90,"type":69},"2026-08",{"date":92,"type":69},"2028-08",{"name":5,"class":6}]