A prospective, single-arm, non-randomized, multi-center, open-label study following patients to 1 year. The study is designed to evaluate the safety and clinical utility of Pulsed Electric Field (PEF) treatment of advanced stage or metastatic cancer following progression on immunotherapy.
This study is designed to evaluate the safety and clinical utility of Pulsed Electric Field (PEF) treatment of advanced stage or metastatic cancer following progression on immunotherapy. The study will enroll adult patients with confirmed 8th ed. Stage IV non-small cell lung cancer (NSCLC), Stage IV renal cell carcinoma (RCC), or Stage IV hepatocellular carcinoma (HCC), who have experienced a response to checkpoint inhibitor (CPI) therapy (complete response (CR), partial response (PR), or stable disease (SD) as per RECIST 1.1) for a minimum of 6 months, and have documented radiologic progression (progressive disease (PD) as defined by RECIST 1.1) in up to five sites (non-central nervous system). PEF treatment delivery is to be performed in conjunction with the clinically appropriate approach to collect standard of care biopsy samples to confirm disease progression. The PI has the discretion to approach via endoluminal or percutaneous method if the target(s) is/are amenable. PEF treatment will be delivered to accessible new areas of growth on existing tumors or new tumors. Treatment may be delivered via either an endoluminal (bronchoscopic) or percutaneous approach at the discretion of the clinical investigator utilizing two available device configurations: * Endoluminal: Galvanize Aliya System with compatible commercially available TBNA Needle and RF probe electrode * Percutaneous: Galvanize Aliya System with compatible commercially available RF needle and RF probe electrode The study will enroll and treat up to 30 adult patients at up to 5 clinical sites.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Patients will undergo pulsed electric field (PEF) treatment of up to 5 tumors (new or progressing) measuring ≤ 2cm in longest diameter.
Prince of Wales Hospital
Shatin, Hong Kong
Radboud University Medical Center
Nijmegen, Netherlands
Hospital Universitario de Salamanca
Salamanca, Spain
Device and Procedure serious adverse event rate
The rate of system-related and procedure-related serious adverse events (SAEs)
Time frame: 30 days
Radiologic local control
Frequency of radiological assessment of response of PEF-treated tumors and lymph nodes (e.g., change in longest diameter of tumor, change in short axis of lymph node)
Time frame: 90 days
Immunologic response: lymphocytes
Changes from baseline in lymphocytes (CD3+, CD4+, CD8+, Treg, NK, Neutrophils MDSC; all analyzed as cells per mL)
Time frame: all time points up to 1 year
Immunologic response: cytokines
Changes from baseline in serum levels of cytokines (IL-2, IL-6, IL-10, IL-12; all analyzed as concentration in pg / mL) from blood samples
Time frame: all time points up to 1 year
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