NCT07539155 Intratumoral MMR Vaccine Injection in Borderline Resectable/Unresectable Pancreatic Cancer
| NCT ID | NCT07539155 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Arkansas |
| Condition | Borderline Resectable/Unresectable Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-06-26 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-06-26 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years. 2. Pathologically proven locally advanced adenocarcinoma of pancreas. 3. Borderline resectable pancreatic cancer that is determined to be unresectable following completion of SoC chemotherapy and RT as evidenced by any of the following: 1. 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. 2. Venous involvement of SMV or portal vein, less than 180 degrees. 3. 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: 4. Greater than 180-degree encasement or occlusion/thrombus of SMA, unresectable SMV, or SMV-portal confluence occlusion. 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. OR Surgeon deems that the pancreatic cancer is unresectable. 4. 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. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6. 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). 7. 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. 8. Adequate renal function (i.e., creatinine less than 1.5 times ULN). Exclusion Criteria: 1. Pancreatic cancer that was either resectable before SoC treatment or became resectable following SoC chemotherapy and RT. 2. Subjects with radiographically proven metastatic disease are excluded. 3. Subject must not be pregnant and/or currently breastfeeding or plan to be. 4. Subject must not have received any live vaccine, including MMR, within 30 days prior to the dose of study drug. 5. 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. 6. Subject has no unresolved toxicities, AEs ≥ Grade 2 (NCI CTCAE version 5.0), from prior anticancer therapy. 7. Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.
Contact & Investigator
Rangaswamy Govindarajan, MD
PRINCIPAL INVESTIGATOR
University of Arkansas
Frequently Asked Questions
Who can join the NCT07539155 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Borderline Resectable/Unresectable Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07539155 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07539155 currently recruiting?
Yes, NCT07539155 is actively recruiting participants. Contact the research team at JAHolley@uams.edu for enrollment information.
Where is the NCT07539155 trial being conducted?
This trial is being conducted at Little Rock, United States.
Who is sponsoring the NCT07539155 clinical trial?
NCT07539155 is sponsored by University of Arkansas. The principal investigator is Rangaswamy Govindarajan, MD at University of Arkansas. The trial plans to enroll 20 participants.
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