Electroporation Potentiated Immunotherapy in Cancer

NCT04835402 | Unknown Phase 2 DMC FDA Drug FDA Device

• 3 other identifiers: EPIC-12020-004536-22N-20200085
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The study is investigating the efficacy and safety of combined irreversible electroporation (IRE) and checkpoint inhibition in metastatic pancreatic cancer.

Conditions

Pancreas Cancer, Metastatic

Keywords

Irreversible electroporation; Pembrolizumab; Immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR) according to RECIST 1.1

  (in patients receiving at least one dose of pembrolizumab, IRE and an evaluable CT-scan)

  6 months after treatment start

• Serious adverse reaction (SAR) rate according to CTCAE v5

  (in patients receiving at least one dose of pembrolizumab)

  cumulative after 12 months after treatment start

Secondary Outcomes (24)

• Median overall survival

  Through study completion, an average of 1 year

• Median progression-free survival

  Through study completion, an average of 1 year

• ORR

  2 months, 4 months and 6 months after treatment start

• Clinical benefit ratio

  8 weeks after treatment start

• Serum CA-19-9 response

  2 months, 4 months and 6 months after treatment start

Study Arms (1)

Intervention

EXPERIMENTAL

Day 1: Pembrolizumab 400mg Day 10: Irreversible electroporation Day 42/84/126/168: Pembrolizumab 400mg

Drug: Pembrolizumab; Device: Irreversible electroporation

Interventions

Pembrolizumab DRUG

400mg every 6 weeks

Also known as: Irreversible electroporation (NanoKnife(tm), Angiodynamics)

Intervention

Irreversible electroporation DEVICE

Percutaneous ablation of one liver metastasis

Also known as: NanoKnife(tm) (Angiodynamics)

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically verified pancreatic adenocarcinoma, based on either a biopsy of the primary tumor or a metastasis
• One liver metastasis treatable by IRE (as determined by MDT at Aalborg University Hospital)
• One tumor lesion suited for repeated biopsy by transcutaneous core needle (preferably another lesion than that used for IRE)
• At least one measurable lesion (RECIST version 1.1) other than the liver metastasis to be treated by IRE
• At least one course of chemotherapy for metastatic or inoperable disease discontinued due to treatment failure or intolerance
• Performance status 0-1
• ASA ≤ 3
• ≥ 18 years of age
• Written and orally informed consent
• Sufficient available histological tumor material stored in biobank or obtainable by new biopsy
• Patient acceptance of collection of blood samples for translational research and two additional biopsies during treatment
• Adequate bone marrow function, liver function, and renal function (within 7 days prior to enrollment):
• Neutrophils (ANC) ≥ 1.5 x 109/l
• Platelet count ≥ 100 x 109/l
• Hemoglobin ≥ 6 mmol/l

You may not qualify if:

• Underlying medical disease not adequately treated (e.g. poorly regulated diabetes and symptomatic cardiac disease)
• Prior or current autoimmune disorder with risk of serious toxicity during treatment with checkpoint inhibitor
• Acute myocardial infarction, cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within 6 months from start of treatment
• Previous reception of allogeneic stem cells or solid organ donation
• Active infection requiring systemic therapy within 7 days prior to treatment initiation
• Positive HIV, HBV, and HCV test results (prior testing or new testing in patients at risk)
• Active psychiatric disease or history of drug or alcohol abuse affecting participation
• Allergy to active substance or any of the auxiliary agents, including known severe allergy to anesthetic agent, paralytic agent or any of the equipment used during treatment
• Expected need for systemic corticosteroid or other systemic immunosuppressive drug during the course of this clinical trial. A low dose of e.g. prednisone ≤ 10 mg/day is permitted for maximally 7 consecutive days
• Coexisting malignant disease, except non-melanoma skin cancer
• Symptomatic or untreated CNS metastases
• Liver cirrhosis Child Pugh \>A
• Women of childbearing potential not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment. Male patients with a fertile partner are also required to secure effective methods of contraception (definition available in protocol)
• Previous immunotherapy
• Patients referred from a hospital outside of Denmark

Sponsors & Collaborators

• Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery: lead
• Odense University Hospital: collaborator
• Aalborg University: collaborator
• Danish Cancer Society: collaborator

Study Sites (1)

Department of Oncology

Aalborg, North Denmark, DK-9000, Denmark

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

pembrolizumab; Electroporation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Morten Ladekarl, DMSc

  Department of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of surgery, Consultant surgeon, DMSc

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 8, 2021
• Study Start: May 26, 2021
• Primary Completion: March 7, 2022
• Study Completion: December 1, 2025
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)