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Pancreatic CancerPhase 1NCT06378047

Irreversible Electroporation & Pembro Immunotherapy in Locally Advanced Pancreatic Cancer

A Phase 1 study testing Pembrolizumab and Irreversible Electroporation in people with Pancreatic Cancer and Locally Advanced Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to determine the safety and tolerability of combining sequential therapy of Irreversible Electroporation (IRE) and Immunotherapy (IO) for patients with locally advanced unresectable pancreas cancer following first-line treatment with chemotherapy and ablative stereotactic magnetic resonance… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab and Irreversible Electroporation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
10 Apr 2024to 15 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Participant must consent to enrollment in the Moffitt Cancer Center (MCC) Total Cancer Care (TCC) Protocol for tissue and blood banking and must have their initial biopsy tissue available.
  • Participant must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, biopsies when required, and other procedures.
  • Histologically or cytologically confirmed PDAC meeting the AJCC 8th edition staging criteria of stage 3 disease.
  • Tumor(s) is/are locally advanced and unresectable pursuant to NCCN guidelines.
  • Participant must be age 18-74 years at diagnosis.
  • Performance-status Eastern Cooperative Oncology Group (ECOG) of 0-1.
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  • Radiologically measurable disease per iRECIST version 1.1.
  • Prior to TCC registration, participants must have no prior therapy for PDAC and fall under treatment NCCN pancreatic adenocarcinoma guides (v1.2022) for locally advanced disease. Before study consent, the participant must have had standard of care first-line therapy consisting of 12 weeks of FOLFIRINOX (at least 6 cycles), followed by 50 Gy of A-SMART, delivered in five 10-Gy fractions. Participant must show no evidence of disease progression after first-line treatment, based upon National Comprehensive Cancer Network (NCCN) guidelines.
  • The maximum axial tumor dimension must be ≤3.5 cm after "first strike" standard of care treatment.
  • Participants must have adequate organ and marrow function.
  • Resolved acute effects of any prior therapy and/or grade ≤1 late toxicity according to CTCAE version 5.0.
  • If a participant requires anticoagulation, treatment must be modified to enoxaparin.
  • Negative serum pregnancy test if female participant is of child-bearing potential. At screening, all female participants of child-bearing age will undergo a urine pregnancy test. If urine test is positive or inconclusive, a serum test will be performed.
  • Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. In addition, WOCBP must agree to continue using adequate contraception for 4 months after pembrolizumab administration. If a woman is breastfeeding, she should stop study drug.
  • Patients must be eligible for standard of care (SoC) NanoKnife therapy.

Who cannot join

  • Clinical evidence of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE), prior history of Cerebral Vascular Accident (CVA), or history of Transient Ischemic Attack (TIA) within 12 months or other known TE event present during the screening period.
  • Clinically significant (i.e., active) cardiovascular disease: myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), serious cardiac arrhythmia requiring medication.
  • Participants who have implanted cardiac pacemakers, defibrillators, or implanted devices with bare metal parts in the thoracic cavity, abdomen, and/or retroperitoneum.
  • Currently receiving treatment with medication that has a known risk to prolong the QT interval or to induce Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment.
  • Participant has other concurrent severe and/or uncontrolled medical conditions that would, in the Investigator's judgment, contraindicate patient participation in the clinical study.
  • Contraindication to heparin as per institutional guidelines.
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  • Another primary cancer within the last 3 years requiring systemic therapy.
  • Participant has had major surgery within 14 days prior to starting study treatment or has not recovered from major side effects.
  • Participant is currently receiving increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent within 2 weeks of study participation or has an active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
  • Participant is being treated at start of study treatment with any of the following drugs: a. Drugs known to be strong or moderate inhibitors or inducers of isoenzyme cytochrome P450 3A4 (CYP3A4), including herbal medications. b. Drugs with a known risk of inducing Torsades de Pointes. Note: The patient must have discontinued strong inducers for at least 1 week and must have discontinued strong inhibitors before the treatment is initiated. Switching to a different medication prior to starting study treatment is allowed.
  • Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  • Known prior severe hypersensitivity to investigational product, hyaluronidase, or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE version 5 grade ≥ 3).
  • Participant has a medically documented poorly controlled psychiatric disorder(s), alcohol abuse, or drug abuse as defined according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V).
  • Gastrointestinal arteriovenous malformations.
  • Local gastrointestinal organ (e.g., stomach, duodenum) invasion by tumor.
  • Participant is unable to undergo magnetic resonance imaging (MRI) due to incompatible implanted device, body habitus, and/or phobia unamenable to anxiolytic therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 1 Study of Irreversible Electroporation and Pembrolizumab Immunotherapy in Locally Advanced Pancreatic Cancer

This study aims to determine the safety and tolerability of combining sequential therapy of Irreversible Electroporation (IRE) and Immunotherapy (IO) for patients with locally advanced unresectable pancreas cancer following first-line treatment with chemotherapy and ablative stereotactic magnetic resonance image-guided adaptive radiation therapy (A-SMART).

Being tested
Pembrolizumab, Irreversible Electroporation
Keywords
Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called Keytruda

    Pembrolizumab is an immunotherapy that will be administered via IV infusion.

  • Irreversible ElectroporationDevice

    Also called NanoKnife

    Participants will undergo IRE as standard of care treatment.

Study groups in NCT06378047
Study groupRoleWhat they receive
IRE/PembrolizumabExperimentalParticipants will undergo irreversible electroporation (IRE) using the NanoKnife system. About 1 week following IRE, study participants will receive a 200mg dose of pembrolizumab.
Receives: Drug: Pembrolizumab; Device: Irreversible Electroporation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

    The number of participants who experience a high-grade (grade 3-5) adverse events based on NCI common terminology criteria for adverse events (CTCAE) version 5 related to treatment.

    Measured: Up to 90 days

Secondary outcomes (3)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from date of diagnosis to the time of first documented tumor progression or death due to any cause, whichever occurs first.

    Measured: Up to 24 months

  2. Overall Survival (OS)

    OS is defined as the time from date of diagnosis to the time of death due to any cause.

    Measured: Up to 24 months

  3. Objective Response Rate (ORR)

    ORR is defined as the proportion of patients with either a partial or complete response according to iRECIST version 1.1 guidelines, measured from date of diagnosis.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study start10 Apr 2024
  3. Primary completion15 Sep 2025
  4. Study completion15 Sep 2025

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06378047
Sponsor's protocol ID
MCC-22325
Status last verified
Feb 2026
First submitted
17 Apr 2024
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pembrolizumab and Irreversible Electroporation in people with Pancreatic Cancer and Locally Advanced Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (time frame: Up to 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06378047.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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