Intratumoral MMR Vaccine Injection in Borderline Resectable/Unresectable Pancreatic Cancer

NCT07539155 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 298471
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Borderline Resectable/Unresectable Pancreatic Cancer; Non Metastatic Pancreatic Cancer

Keywords

MMR; Borderline Resectable; Borderline Unresectable; Pancreatic Cancer; Non-Metastatic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The clinical efficacy of MMR vaccines will be assessed according to RECIST 1.1

  At screening and every 12 weeks from day 1 for 2 years

Other Outcomes (1)

• Immune response dynamics following treatment with MMR

  From MMR injection to week 8

Study Arms (1)

Intratumoral MMR Injection

EXPERIMENTAL

Biological: Intratumoral MMR Injection

Interventions

Intratumoral MMR Injection 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. The injection will be at least 6 weeks but no later than 12 weeks post completion of chemo-radiation therapy.

Intratumoral MMR Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• a. 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.

You may not qualify if:

• 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.
• Subject must not be pregnant and/or currently breastfeeding or plan to be.
• 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.
• Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.

Sponsors & Collaborators

• University of Arkansas: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Rangaswamy Govindarajan, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Holley, BS

CONTACT

501-214-2499; JAHolley@uams.edu

Jennifer Faulkner, MS

CONTACT

501-214-2499; JLFaulkner@uams.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The IPD and supporting information will be available from the trials starting date until the professor leaves the institution.
• Access Criteria: Specific researchers that are listed in the data transfer agreement will be able to access the dataset which 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. They will access this dataset via institutional BOX access.