Borderline Resectable/Unresectable Pancreatic CancerPhase 1/2NCT07539155
Intratumoral MMR Vaccine Injection in Borderline Resectable/Unresectable Pancreatic Cancer
A Phase 1/2 study testing Intratumoral MMR Injection in people with Borderline Resectable/Unresectable Pancreatic Cancer and Non Metastatic Pancreatic Cancer, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Resectable/Unresectable Pancreatic Cancer, Non Metastatic Pancreatic Cancer
- What is being tested?
- Intratumoral MMR Injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2026to Aug 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Maroof Zafar, 501-686-8274
Joseph Holley, 501-686-8274
About this study
Official title: Phase 1b/2 Study of Intratumoral MMR Vaccine Injection in Borderline Resectable/Unresectable Pancreatic Cancer
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.
Read the detailed description
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.
- Being tested
- Intratumoral MMR Injection
- Keywords
- MMR, Borderline Resectable, Borderline Unresectable, Pancreatic Cancer, Non-Metastatic
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intratumoral MMR InjectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Intratumoral MMR Injection | Experimental | Not described Receives: Biological: Intratumoral MMR Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 weeks post injection
Secondary outcomes (1)
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.
Measured: At screening and every 12 weeks from day 1 for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start26 Jun 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Resectable/Unresectable Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rangaswamy Govindarajan, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539155
- Sponsor's protocol ID
- 298471
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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