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Clinical Trial Record

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Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer

2022-09-08

2023-08-30

2023-08-30

9

Study Overview

Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer

The trial investigates the safety and efficacy of irreversible electroporation in combination with checkpoint inhibition in patients with metastatic pancreatic cancer.

The trial is designed as an investigator initiated prospective phase 2 study in patients with metastatic pancreatic cancer (PC) to determine the efficacy and safety of checkpoint inhibition administered concurrently with irreversible electroporation. A recently published preclinical study by Zhao et al. (2019) showed that the combination of IRE and PD-1-inhibitor suppressed the tumour growth and increased the survival of mice bearing pancreatic cancer. The aim of the trial is to initiate an abscopal response, leveraging the patient's immune system in eliciting a sufficient immune response.

  • Pancreas Cancer
  • DRUG: Nivolumab
  • DEVICE: Irreversible electroporation (IRE)
  • 26092020
  • 2020-004623-17 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2022-06-22  

N/A  

2023-09-13  

2022-06-27  

N/A  

2023-09-15  

2022-06-28  

N/A  

2023-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: IRE + Nivolumab

IRE on Day 1, followed by Nivolumab on Day 2/3 and then every 2 weeks (q2w) for a maximum of 24 weeks.

DRUG: Nivolumab

  • Every 2 weeks (3 mg/kg, maximum of 240 mg) for up to 24 weeks Nivolumab is an immune checkpoint inhibitor (PD-1-inhibitor).

DEVICE: Irreversible electroporation (IRE)

  • Percutaneous ablation of a primary in-situ (or locally-recurrent) or metastatic lesion. Irreversible electroporation is delivered through the NanoKnife system (AngioDynamics, New York, USA). The system is FDA-approved for medical use.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of treatment related adverse events [Safety and Tolerability]Determined by the incidence and severity of treatment related adverse events according to CTCAE version 4.06 months after start of treatment
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Tumor response by CTBased on CT chest/abdomen scans according to RECIST version 1.1Baseline compared to 3 and 6 months after start of treatment
Tumor response by ultrasoundBased on contrast enhanced ultrasound (CEUS) utilizing the standardized and quantitative method Dynamic CEUS (DCEUS)Baseline compared to 3 and 6 months after start of treatment
Progression free survivalIn terms of monthsFrom start of treatment until unequivocal disease progression, assessed up to 5 years
Overall survivalIn terms of monthsFrom start of treatment until unequivocal disease progression, assessed up to 5 years
Quality of life using EORTC QLQ-C30EORTC QLQ-C30Baseline compared to 14 days, 3 and 6 months after start of treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Signed informed consent. 2. Histopathological confirmation of pancreatic adenocarcinoma. 3. At least one measurable primary in-situ (or locally-recurrent) or metastatic tumor must be present and, in the opinion of the investigators be amenable to IRE, and at least one additional metastatic tumor that will not undergo IRE. Both lesions must be accessible for image-guided percutaneous biopsy. 4. Age > 18 years 5. Life expectancy greater than 3 months 6. ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) 0-1 7. Patients must have normal organ and marrow function as defined below:

  • White blood cell count (WBC) ≥ 2 x 10⁹/L
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
  • Hemoglobin ≥ 5,6 mmol/l
  • Platelet count ≥ 100 x 10⁹/L
  • Serum bilirubin ≤1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol/L )
  • ASAT/ALAT ≤3 x ULN ( < 5 x ULN if known liver metastasis)
  • PP ≥ 40 or INR ≤ 1.5
  • Serum creatinine ≤ 1.5 x ULN or eGFR ≥ 40 mL/min 8. Women of childbearing potential (WOCBP) must use method(s) of contraception as indicated per protocol. 9. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab. 10. Women must not be breastfeeding 11. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. 12. Men who are sexually active with WOCBP must continue contraception for 31 weeks (90 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug.

    • Exclusion Criteria:
    1. Malignant ascites that is clinically detectable by physical examination or is symptomatic. 2. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways 3. Radiotherapy, or major surgery within the last 2 weeks prior to entering the study 4. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results. 5. Patients should be excluded if they have an active, known or suspected autoimmune disease. 6. Patients should be excluded if they are positive test for hepatitis B virus surface anti-gen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection 7. Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immuno-suppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 8. PD-1 inhibitors may cause hepatic toxicity which may lead to caution regarding other potentially hepatotoxic drugs. 9. Allergies and Adverse Drug Reaction

  • History of allergy to study drug components
  • History of severe hypersensitivity reaction to any monoclonal antibody 10. Patients are excluded if they have active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for [lowest minimum is 4 weeks or more] after treatment is complete and within 28 days prior to the first dose of nivolumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration 11. Contraindications for IRE:


  • Implanted pacemaker or ICD (Implantable cardioverter defibrillator) unit.
  • History of epilepsy
  • History of cardiac arrhythmia
  • Recent myocardial infarction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Ismail Gögenur, Professor, Zealand University Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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