A Phase 1/2 interventional study of Intratumoral MMR Injection in Borderline Resectable/Unresectable Pancreatic Cancer and Non Metastatic Pancreatic Cancer, sponsored by University of Arkansas. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by University of Arkansas · Phase 1/2, Interventional, and Treatment
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.
This is a prospective single-arm phase Ib/II study for subjects with locally advanced, borderline resectable / 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/capecitabine, per physician's choice) will be eligible for the study if the tumor did not become resectable following the therapy just described.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 20 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Borderline resectable pancreatic cancer that is determined to be unresectable following completion of SoC chemotherapy and RT as evidenced by any of the following:
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:
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).
a. The chemo-radiation therapy regimen should be completed at least 6 weeks but no more than 12 weeks from planned Day 1.
Exclusion Criteria:
Biological: Intratumoral MMR Injection
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. The injection will be at least 6 weeks but no later than 12 weeks post completion of chemo-radiation therapy.
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.
Time frame: Baseline to 4 weeks post injection
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. A 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.
Time frame: At screening and every 12 weeks from day 1 for 2 years
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
Time frame: From MMR injection to week 8
Plan to share: Yes — De-identified clinical and biochemical data derived from human subjects enrolled in the phase I study evaluating intratumoral administration of the MMR vaccine in patients with locally advanced, borderline resectable, or unresectable non-metastatic pancreatic cancer following standard-of-care chemotherapy and radiation therapy. The dataset will include patient demographic information (de-identified), treatment details, safety outcomes, imaging-based tumor response assessments, immune profiling data (e.g., T-cell response measurements), and circulating tumor DNA (ctDNA) analyses. The data will be generated from approximately 20 subjects enrolled under the study protocol titled "Phase 1b/2 Study of Intratumoral MMR Vaccine Injection in Borderline Resectable/Unresectable Pancreatic Cancer." All data will be de-identified prior to sharing and transmitted securely via Box for the purposes of collaborative analysis, manuscript preparation, and grant develop
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Arkansas