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About
The trial investigates the safety and efficacy of irreversible electroporation in combination with checkpoint inhibition in patients with metastatic pancreatic cancer.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed informed consent.
Histopathological confirmation of pancreatic adenocarcinoma.
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.
Age > 18 years
Life expectancy greater than 3 months
ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) 0-1
Patients must have normal organ and marrow function as defined below:
Women of childbearing potential (WOCBP) must use method(s) of contraception as indicated per protocol.
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.
Women must not be breastfeeding
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year.
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
Malignant ascites that is clinically detectable by physical examination or is symptomatic.
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
Radiotherapy, or major surgery within the last 2 weeks prior to entering the study
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.
Patients should be excluded if they have an active, known or suspected autoimmune disease.
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
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.
PD-1 inhibitors may cause hepatic toxicity which may lead to caution regarding other potentially hepatotoxic drugs.
Allergies and Adverse Drug Reaction
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
Contraindications for IRE:
Primary purpose
Allocation
Interventional model
Masking
9 participants in 1 patient group
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Central trial contact
Ismail Gögenur, Professor; Tobias F Justesen, MD
Data sourced from clinicaltrials.gov
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