Pancreatic AdenocarcinomaPhase 2NCT03080974
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
A Phase 2 study testing Nivolumab and Irreversible Electroporation in people with Pancreatic Adenocarcinoma, run by University of Louisville at 1 site in United States.
Trial summary
Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Nivolumab and Irreversible Electroporation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 1 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- ≥ 18 years if age
- Diagnosed with stage III pancreatic cancer
- Tumor is measurable
- Glomerular Filtration Rate > 60 m/L/min/1.73 m(2)
- Willing and able to comply with the protocol requirements
- Able to comprehend and have signed the informed consent to participate
Who cannot join
- Participating in another clinical trial for the treatment of cancer at time of screening
- Are pregnant or currently breast feeding
- Have a cardiac pacemaker or Implantable Cardioverter Defibrillator implanted that cannot be deactivated during the procedure
- Have non-removable implants with metal parts within 1 cm of the target lesion
- Had a myocardial infarction within 3 months prior to enrollment
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 Louisville
Louisville, Kentucky, 40202
About this study
Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.
Read the detailed description
Immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. This is a Phase II study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Nivolumab, Irreversible Electroporation
- Keywords
- irreversible electroporation, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Given post-operatively every two weeks for a total of 4 doses. Dose based on weight.
Irreversible ElectroporationProcedure or surgery
Non-thermal ablation of tumor
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All patients undergoing irreversible electroporation will be treated with nivolumab Receives: Drug: Nivolumab; Procedure: Irreversible Electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment
Adverse events and Serious adverse events will be collected
Measured: Baseline thru 100 days after receiving last dose
Secondary outcomes (2)
Progression Free Survival
CT scans will be reviewed
Measured: Every three months for 4 years.
Overall Survival
CT scans will be reviewed
Measured: Every three months for 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start14 Aug 2017
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will undergo irreversible electroporation and treatment with Nivolumab
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert C. Martin, University of Louisville
- Investigators
- Robert Martin, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080974
- Sponsor's protocol ID
- 16.1190
- Status last verified
- Oct 2025
- First submitted
- 14 Feb 2017
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03080974
- Acronym / sponsor ID
- 16.1190
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- irreversible electroporation, Nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.
Detailed description
Immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. This is a Phase II study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will undergo irreversible electroporation and treatment with Nivolumab
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Nivolumab, Procedure: Irreversible ElectroporationAll patients undergoing irreversible electroporation will be treated with nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years if age
- Diagnosed with stage III pancreatic cancer
- Tumor is measurable
- Glomerular Filtration Rate > 60 m/L/min/1.73 m(2)
- Willing and able to comply with the protocol requirements
Key exclusion criteria (5 listed)
- Participating in another clinical trial for the treatment of cancer at time of screening
- Are pregnant or currently breast feeding
- Have a cardiac pacemaker or Implantable Cardioverter Defibrillator implanted that cannot be deactivated during the procedure
- Have non-removable implants with metal parts within 1 cm of the target lesion
- Had a myocardial infarction within 3 months prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabGiven post-operatively every two weeks for a total of 4 doses. Dose based on weight. | Drug | Single Arm |
| Irreversible ElectroporationNon-thermal ablation of tumor | Procedure or surgery | Single Arm |
Primary outcome
Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment
Time frame: Baseline thru 100 days after receiving last dose
Adverse events and Serious adverse events will be collected
2 secondary outcomes
Progression Free Survival
Time frame: Every three months for 4 years.
Overall Survival
Time frame: Every three months for 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Martin, MD, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Irreversible Electroporation in people with Pancreatic Adenocarcinoma, run by University of Louisville 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Oct 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Martin, MD, PhD (502-629-3355, robert.martin@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment (time frame: Baseline thru 100 days after receiving last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2025.