Pancreatic CancerPhase 1NCT04612530
PANFIRE-3 Trial: Assessing Safety and Efficacy of Irreversible Electroporation (IRE) + Nivolumab + CpG for Metastatic Pancreatic Cancer
A Phase 1 study testing Irreversible Electroporation (IRE), Nivolumab and Toll-Like Receptor 9 in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Irreversible electroporation is a local ablative technique used in the treatment of pancreatic cancer. In addition to its cytoreductive ability, IRE also induces a systemic immune response. However, this immune response is not potent enough to establish durable regression of the tumor. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- Irreversible Electroporation (IRE), Nivolumab and Toll-Like Receptor 9
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2020to 1 Jun 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiological and histopathologically proven stage IV pancreatic cancer (according to the AJCC staging system for pancreatic cancer);
- Primary oligometastatic disease, defined as at least 1 hepatic metastasis but occurrence of other metastases is not necessarily restricted to the liver, maximum of metastases is to be determined on a case by case basis by the multidisciplinary tumor board.
- Primary tumor is in situ.
- A minimum of 4 cycles of FOLFIRINOX chemotherapy is required but with the explicit aim to strive for completion of 8 cycles of FOLFIRINOX before study inclusion, with at least stable disease on CTscan.
- Age ≥ 18 years.
- World Health Organisation scale (WHO) performance status 0 - 2;
- Adequate bile drainage in case of biliary obstruction.
Who cannot join
- Trans-mucosal tumor invasion into surrounding duodenum or stomach;
- Active epilepsy (last convulsion < 5 years);
- History of cardiac disease:
- Congestive heart failure > NYHA Class 2
- Active coronary artery disease (defined as myocardial infarction within 6 months prior to screening);
- Ventricular cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted; atrial fibrillation is not contra-indicated);
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- Known hypersensitivity to any oligodeoxynucleotides.
- Compromised liver function defined as warning signs of portal hypertension, INR > 1,5 without use of anticoagulants, bilirubin > x 1.5 Upper limit of normal range (ULN) ASAT >3.0 x ULN, ALAT >3.0 x ULN.
- Compromised kidney function defined as eGFR <30 ml/min (using the Cockcroft Gault formula);
- Active autoimmune disease requiring disease-modifying therapy at the time of screening: i.e. > 10 mg prednisolone per day or equivalent to this regimen.
- Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
- Uncontrolled infections (> grade 2 NCI-CTC version 3.0); requiring antibiotics
- Pregnant or breast-feeding subjects; Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment;
- Immunotherapy prior to the procedure for the treatment of cancer;
- Previous surgical therapy for pancreatic cancer;
- Second primary malignancy with median 5 year OS < 90%, this excludes adequately treated cancers like: non-melanoma skin cancer, in situ carcinoma of the cervix uteri, superficial bladder cancer or other malignancies treated previously without signs of recurrence.
- Allergy to contrast agent.
- Allergy to PET tracers 18F-FDG and 18F-BMS-986192 Zr-89-Nivolumab
- Any implanted stimulation device;
- Portal vein or VMS stenosis > 70% (relative contra-indication)
- Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Centre (location VUmc)
Amsterdam, North Holland, 1081HV
Florentine EF Timmer, MSc, +3120 444 4571, f.timmer1@amsterdamumc.nl
Bart Geboers, MD, +3120 444 4571, b.geboers@amsterdamumc.nl
About this study
Official title: Irreversible Electroporation and Nivolumab Combined With Intratumoral Administration of a Toll-like Receptor Ligand as a Means of in Vivo Vaccination for Oligometastatic Pancreatic Ductal Adenocarcinoma
Irreversible electroporation is a local ablative technique used in the treatment of pancreatic cancer. In addition to its cytoreductive ability, IRE also induces a systemic immune response. However, this immune response is not potent enough to establish durable regression of the tumor. The immune response can be leveraged by combining IRE with immunotherapy. The primary aim of this study is to determine the safety of IRE + Nivolumab (arm B) and IRE + Nivolumab + CpG (arm C). The secondary aim is to assess efficacy of the experimental arms (B, C) and control arm A (Nivolumab monotherapy), based on overall and progression-free survival as well as locoregional and systemic immune modulation.
Read the detailed description
Pancreatic carcinoma is one of the deadliest types of cancer. In contrast to other cancers, new treatment options have demonstrated only moderate improvements for pancreatic cancer in terms of overall survival. Patients with metastasized disease (stage IV, AJCC) that are treated with chemotherapy in the Netherlands currently present a median overall survival of 6.4 months. Previous research has shown promising results for patients with locally advanced pancreatic cancer (LAPC, stage III, AJCC) with regards to combination treatment with chemotherapy and irreversible electroporation (IRE), a local ablation technique that utilizes electrical pulses to destroy cancerous tissue. In addition to an increase in overall survival, IRE induced a systemic immune response. However, the immune response was not potent enough to generate a lasting anti-tumor effect. Leveraging the body's own immune response by using local and systemic immunotherapy may create a synergistic effect, potentially inducing a durable anti-tumor response. The PANFIRE-III is a prospective randomised phase 1 trial with the primary aim to determine safety of the combination therapies IRE + Nivolumab (arm B) and CpG + IRE + Nivolumab (arm C) in patients with oligo-metastasized pancreatic cancer. The secondary goal is to determine efficacy of the experimental arms (arm B, C) compared to the control arm A (Nivolumab monotherapy). This will be assessed by looking at the overall and progression-free survival as well as the locoregional and systemic immune response. The treatment combination of IRE with immunotherapy has the potential to generate systemic protection by in vivo vaccination against pancreatic cancer cells, hereby inhibiting both local and distant tumor growth.
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- Being tested
- Irreversible Electroporation (IRE), Nivolumab, Toll-Like Receptor 9
- Keywords
- pancreatic cancer, metastatic pancreatic cancer, pancreatic ductal adenocarcinoma, metastatic pancreatic ductal adenocarcinoma, PDAC
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible Electroporation (IRE)Device
Irreversible electroporation (IRE) is a local ablative technique that utilizes electrical pulses to destroy tumor tissue
NivolumabDrug
Nivolumab is an immune checkpoint inhibitor targeting the PD-1 receptor on T-cells. Binding of the PD-1 monoclonal antibody onto the PD-1 receptor blocks the brake signal on the T-cells, allowing them to attack the cancer cells.
Toll-Like Receptor 9Drug
Toll-Like Receptor 9 (CpG) is an oligodeoxynucleotide that stimulates dendritic cells to release IFN type I, activating natural killer and infiltrating T cells. This creates a more pro-immunogenic tumor environment.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Nivolumab | Active comparator | 4 weeks after pre-treatment with FOLFIRINOX (4-8 cycles), the patient will start with the Nivolumab scheme. The first month, a biweekly dose of 240 mg will be administered, followed by a monthly dose of 480 mg. This treatment will continue until disease progression. Receives: Drug: Nivolumab |
| Arm B: IRE + Nivolumab | Experimental | 4 weeks after pre-treatment with FOLFIRINOX (4-8 cycles), the patient will first receive (an incomplete) IRE of the primary pancreatic tumor. 2 weeks thereafter, they will start the Nivolumab scheme. The first month, a biweekly dose of 240 mg will be administered, followed by a monthly dose of 480 mg. This treatment will continue until disease progression. Receives: Device: Irreversible Electroporation (IRE); Drug: Nivolumab |
| Arm C: CpG + IRE + Nivolumab | Experimental | 4 weeks after pre-treatment with FOLFIRINOX (4-8 cycles), a toll-like receptor ligand (CpG) will be administered into the primary pancreatic tumor. A week later, the patient will receive (an incomplete) IRE of the primary tumor. 2 weeks thereafter, they will start the Nivolumab scheme. The first month, a biweekly dose of 240 mg will be administered, followed by a monthly dose of 480 mg. This treatment will continue until disease progression. Receives: Device: Irreversible Electroporation (IRE); Drug: Nivolumab; Drug: Toll-Like Receptor 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the combination treatment IRE + immunotherapy based on adverse events
Determined by the treatment related (serious) adverse events
Measured: From randomization until 1 year later
Secondary outcomes (14)
Overall Survival
Overall survival in terms of months
Measured: From date of randomization until death, assessed up to 5 years
Progression-Free Survival
Progression-free survival in terms of months
Measured: From date of randomization until unequivocal disease progression, assessed up to 5 years
Immunomodulation (local)
The local immune response will be assessed using flow cytometry and immunohistochemistry of 2 biopsies (1x primary, 1x metastasis). Markers include those of T-cells, dendritic cells and others.
Measured: Biopsies taken at T=0 (prior to treatment), T=2 weeks and T=6 weeks
Immunomodulation (systemic)
The systemic immune response will be assessed using flow cytometry of peripheral blood. Markers include those of T-cells, dendritic cells, MDSCs, NK cells.
Measured: Blood taken at T=0 (prior to treatment), T=2 weeks and T=6 weeks
Tumor Response on Imaging
Tumor response will be assessed using PET-CT scans: tracer uptake of FDG and PD-L1. CT scans will be employed to determine tumor response based on the RECIST criteria.
Measured: PET scans at T= 0 (prior to treatment), T= 6 weeks and T=3months. CT scans will be made at T= 0 (prior to treatment), T= 6 weeks, T=3months, followed by a scan every subsequent 3 months (T=6m,9m,12m etc) until unequivocal disease progression.
Quality of Life throughout treatment based on overall health
Based on the following EORTC questionnaire: EQ-5D-L5. Question types include: scale 1-5
Measured: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on specific health questions
Based on the following EORTC questionnaire: QLQ-C30 Question types include: scale 1-5, scale 1-7
Measured: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on Chemotherapy-Induced Peripheral Neuropathy
Based on the following EORTC questionnaire: QLQ-CIPN20 Question types include: scale 1-4
Measured: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment specifically in patients with pancreatic cancer
Based on the following EORTC questionnaire: QLQ-PAN26 Question types include: scale 1-4
Measured: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on the patient's happiness and emotional functioning
Based on the following questionnaire: QLQ-HAPINES Question types include: scale 1-10
Measured: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on anxiety and depression
Based on the following questionnaire: QLQ-HADS Question types include: scale 1-4
Measured: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on a patient's psychological state regarding their disease
Based on the following questionnaire: QLQ-WOPS Question types include: scale 1-4, scale 1-10, yes/no, open
Measured: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on (decreased) pancreatic functionality
Based on the following questionnaire: EPI Question types include: 5 optional answers, scale, 1-4, scale 1-5, yes/no, open
Measured: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Pain based on the Visual Analog Score (VAS)
The pain questionnaire is based on the VAS and includes scale type questions (1 - 10) with higher scores referring to more pain.
Measured: Pain will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Sep 2020
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Step-up design. Arms A (monotherapy Nivolumab, 6 patients) and B (IRE + Nivolumab, 6 patients) will open first. A safety and toxicity analysis will be performed after the inclusion of patient 6 and patient 12. Arm C (CpG + IRE + Nivolumab, 6 patients) will open if the interim results demonstrate safety of arms A and B.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. M.R. Meijerink, Amsterdam UMC, location VUmc
- Investigators
- Martijn R Meijerink, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612530
- Sponsor's protocol ID
- 2020.231 - NL73415.029.20
- Status last verified
- Dec 2022
- First submitted
- 9 Sep 2020
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irreversible Electroporation and Nivolumab Combined With Intratumoral Administration of a Toll-like Receptor Ligand as a Means of in Vivo Vaccination for Oligometastatic Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04612530
- Acronym / sponsor ID
- 2020.231 - NL73415.029.20
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- Keywords
- pancreatic cancer, metastatic pancreatic cancer, pancreatic ductal adenocarcinoma, metastatic pancreatic ductal adenocarcinoma, PDAC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 3 Nov 2020 (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.
Irreversible electroporation is a local ablative technique used in the treatment of pancreatic cancer. In addition to its cytoreductive ability, IRE also induces a systemic immune response. However, this immune response is not potent enough to establish durable regression of the tumor. The immune response can be leveraged by combining IRE with immunotherapy. The primary aim of this study is to determine the safety of IRE + Nivolumab (arm B) and IRE + Nivolumab + CpG (arm C). The secondary aim is to assess efficacy of the experimental arms (B, C) and control arm A (Nivolumab monotherapy), based on overall and progression-free survival as well as locoregional and systemic immune modulation.
Detailed description
Pancreatic carcinoma is one of the deadliest types of cancer. In contrast to other cancers, new treatment options have demonstrated only moderate improvements for pancreatic cancer in terms of overall survival. Patients with metastasized disease (stage IV, AJCC) that are treated with chemotherapy in the Netherlands currently present a median overall survival of 6.4 months. Previous research has shown promising results for patients with locally advanced pancreatic cancer (LAPC, stage III, AJCC) with regards to combination treatment with chemotherapy and irreversible electroporation (IRE), a local ablation technique that utilizes electrical pulses to destroy cancerous tissue. In addition to an increase in overall survival, IRE induced a systemic immune response. However, the immune response was not potent enough to generate a lasting anti-tumor effect. Leveraging the body's own immune response by using local and systemic immunotherapy may create a synergistic effect, potentially inducing a durable anti-tumor response. The PANFIRE-III is a prospective randomised phase 1 trial with the primary aim to determine safety of the combination therapies IRE + Nivolumab (arm B) and CpG + IRE + Nivolumab (arm C) in patients with oligo-metastasized pancreatic cancer. The secondary goal is to determine efficacy of the experimental arms (arm B, C) compared to the control arm A (Nivolumab monotherapy). This will be assessed by looking at the overall and progression-free survival as well as the locoregional and systemic immune response. The treatment combination of IRE with immunotherapy has the potential to generate systemic protection by in vivo vaccination against pancreatic cancer cells, hereby inhibiting both local and distant tumor growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Step-up design. Arms A (monotherapy Nivolumab, 6 patients) and B (IRE + Nivolumab, 6 patients) will open first. A safety and toxicity analysis will be performed after the inclusion of patient 6 and patient 12. Arm C (CpG + IRE + Nivolumab, 6 patients) will open if the interim results demonstrate safety of arms A and B.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Nivolumab | Active comparator | Drug: Nivolumab4 weeks after pre-treatment with FOLFIRINOX (4-8 cycles), the patient will start with the Nivolumab scheme. The first month, a biweekly dose of 240 mg will be administered, followed by a monthly dose of 480 mg. This treatment will continue until disease progression. |
| Arm B: IRE + Nivolumab | Experimental | Device: Irreversible Electroporation (IRE), Drug: Nivolumab4 weeks after pre-treatment with FOLFIRINOX (4-8 cycles), the patient will first receive (an incomplete) IRE of the primary pancreatic tumor. 2 weeks thereafter, they will start the Nivolumab scheme. The first month, a biweekly dose of 240 mg will be administered, followed by a monthly dose of 480 mg. This treatment will continue until disease progression. |
| Arm C: CpG + IRE + Nivolumab | Experimental | Device: Irreversible Electroporation (IRE), Drug: Nivolumab, Drug: Toll-Like Receptor 94 weeks after pre-treatment with FOLFIRINOX (4-8 cycles), a toll-like receptor ligand (CpG) will be administered into the primary pancreatic tumor. A week later, the patient will receive (an incomplete) IRE of the primary tumor. 2 weeks thereafter, they will start the Nivolumab scheme. The first month, a biweekly dose of 240 mg will be administered, followed by a monthly dose of 480 mg. This treatment will continue until disease progression. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Radiological and histopathologically proven stage IV pancreatic cancer (according to the AJCC staging system for pancreatic cancer);
- Primary oligometastatic disease, defined as at least 1 hepatic metastasis but occurrence of other metastases is not necessarily restricted to the liver, maximum of metastases is to be determined on a case by case basis by the multidisciplinary tumor board.
- Primary tumor is in situ.
- A minimum of 4 cycles of FOLFIRINOX chemotherapy is required but with the explicit aim to strive for completion of 8 cycles of FOLFIRINOX before study inclusion, with at least stable disease on CTscan.
- Age ≥ 18 years.
Key exclusion criteria (21 listed)
- Trans-mucosal tumor invasion into surrounding duodenum or stomach;
- Active epilepsy (last convulsion < 5 years);
- History of cardiac disease:
- Known hypersensitivity to any oligodeoxynucleotides.
- Compromised liver function defined as warning signs of portal hypertension, INR > 1,5 without use of anticoagulants, bilirubin > x 1.5 Upper limit of normal range (ULN) ASAT >3.0 x ULN, ALAT >3.0 x ULN.
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 |
|---|---|---|
| Irreversible Electroporation (IRE)Irreversible electroporation (IRE) is a local ablative technique that utilizes electrical pulses to destroy tumor tissue | Device | Arm B: IRE + Nivolumab, Arm C: CpG + IRE + Nivolumab |
| NivolumabNivolumab is an immune checkpoint inhibitor targeting the PD-1 receptor on T-cells. Binding of the PD-1 monoclonal antibody onto the PD-1 receptor blocks the brake signal on the T-cells, allowing them to attack the cancer cells. | Drug | Arm A: Nivolumab, Arm B: IRE + Nivolumab, Arm C: CpG + IRE + Nivolumab |
| Toll-Like Receptor 9Toll-Like Receptor 9 (CpG) is an oligodeoxynucleotide that stimulates dendritic cells to release IFN type I, activating natural killer and infiltrating T cells. This creates a more pro-immunogenic tumor environment. | Drug | Arm C: CpG + IRE + Nivolumab |
Primary outcome
Safety of the combination treatment IRE + immunotherapy based on adverse events
Time frame: From randomization until 1 year later
Determined by the treatment related (serious) adverse events
14 secondary outcomes
Overall Survival
Time frame: From date of randomization until death, assessed up to 5 years
Progression-Free Survival
Time frame: From date of randomization until unequivocal disease progression, assessed up to 5 years
Immunomodulation (local)
Time frame: Biopsies taken at T=0 (prior to treatment), T=2 weeks and T=6 weeks
Immunomodulation (systemic)
Time frame: Blood taken at T=0 (prior to treatment), T=2 weeks and T=6 weeks
Tumor Response on Imaging
Time frame: PET scans at T= 0 (prior to treatment), T= 6 weeks and T=3months. CT scans will be made at T= 0 (prior to treatment), T= 6 weeks, T=3months, followed by a scan every subsequent 3 months (T=6m,9m,12m etc) until unequivocal disease progression.
Quality of Life throughout treatment based on overall health
Time frame: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on specific health questions
Time frame: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on Chemotherapy-Induced Peripheral Neuropathy
Time frame: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment specifically in patients with pancreatic cancer
Time frame: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on the patient's happiness and emotional functioning
Time frame: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on anxiety and depression
Time frame: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on a patient's psychological state regarding their disease
Time frame: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Quality of Life throughout treatment based on (decreased) pancreatic functionality
Time frame: Quality of Life will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Pain based on the Visual Analog Score (VAS)
Time frame: Pain will be assessed every 3 months (T=0 (baseline), T=3months, etc) up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Martijn R Meijerink, MD, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Irreversible Electroporation (IRE), Nivolumab and Toll-Like Receptor 9 in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 20 Dec 2022. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florentine EF Timmer, MSc (+3120 444 4571, f.timmer1@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the combination treatment IRE + immunotherapy based on adverse events (time frame: From randomization until 1 year later). 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 20 Dec 2022.