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Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer

Irreversible Electroporation in Combination With Immune Checkpoint Inhibition, in Patients With Metastatic Pancreatic Cancer - A Prospective, Phase 2 Study

NCT05435053•Ismail Gögenur

View on ClinicalTrials.gov

Summary

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

Detailed 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.

Eligibility

Age

18 - 100 years

Sex

ALL

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
+15 more criteria

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
+1 more criteria

Locations (1)

Zealand University Hospital

Roskilde, Denmark

Key Dates

Start Date

September 8, 2022

Primary Completion Date

August 30, 2023

Completion Date

August 30, 2023

Last Updated

September 15, 2023

Enrollment

ACTUAL participants

Conditions

Pancreas Cancer

Interventions

Nivolumab

DRUG

Irreversible electroporation (IRE)

DEVICE

Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury

NCT04485286

Lung CancerRadiation Fibrosis+2 more

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RECRUITINGPHASE1/PHASE2

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

NCT04605913

Pancreas CancerMetastatic Pancreatic Cancer+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury

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