A Clinical Evaluation of the Aliya™ System in Late Stage Cancer

NCT04773275 | Terminated FDA Device

• 1 other identifier: CSP-00010
• Study Type: interventional
• Target: 4
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Cancer of Lung, Kidney or Liver

Outcome Measures

Primary Outcomes (2)

• Device and Procedure serious adverse event rate

  The rate of system-related and procedure-related serious adverse events (SAEs)

  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)

  90 days

Secondary Outcomes (2)

• Immunologic response: lymphocytes

  all time points up to 1 year

• Immunologic response: cytokines

  all time points up to 1 year

Other Outcomes (5)

• Procedural Success

  Time of procedure

• Duration of checkpoint inhibitor treatment

  12 months

• Patient progression free survival (PFS)

  90 days

Study Arms (1)

Aliya PEF treatment

EXPERIMENTAL

Device: Pulsed electric field treatment using the Aliya system

Interventions

Pulsed electric field treatment using the Aliya system DEVICE

Patients will undergo pulsed electric field (PEF) treatment of up to 5 tumors (new or progressing) measuring ≤ 2cm in longest diameter.

Aliya PEF treatment

Eligibility Criteria

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

You may qualify if:

• Stage IV non-small cell lung cancer
• Stage IV hepatocellular carcinoma
• Stage IV renal cell carcinoma
• Patient is currently receiving PD-1/PD-L1 axis immunotherapy as their most recent line of therapy, either alone or in combination with standard of care systemic therapy for their malignancy.
• Patient has exhibited at least 6 months of response to PD-1/PD-L1 axis immunotherapy regimen (defined as complete response (CR), partial response (PR), or stable disease (SD) in their index tumors per RECIST 1.1) prior to progression.
• Patient has radiologically documented or confirmed progressive disease (per RECIST 1.1) defined as a total of ≤ 5 new areas of growth on existing tumors and/or new tumors.
• New tumors must be ≤ 2cm in longest diameter. New areas of growth on existing tumors must be ≤ 2cm in longest diameter. Tumors and new areas of growth must be deemed suitable by the investigator for complete treatment with PEF. Pathologic lymph nodes must be ≥ 15mm in short axis.
• In the judgement of the investigator, the patient is able to remain on PD-1/PD-L1 axis immunotherapy for at least 3 months after PEF treatment.
• New tumors and areas of growth on existing tumors are amenable to core or forceps biopsy in order to confirm disease progression.
• Patient must be willing to undergo tumor biopsy at PEF treatment delivery.
• Patient refuses surgery and/or stereotactic body radiotherapy (SBRT).
• Life expectancy ≥ 12 weeks.
• ECOG performance status 0-1

You may not qualify if:

• Patient has implanted lung devices or electronic devices.
• Patient is receiving bevacizumab concurrently with their PD-1/PD-L1 axis immunotherapy.
• Patient has received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) in another study within 21 days prior to study enrollment.
• Patient is scheduled to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for off-label cancer treatment while on this study.
• Patient has unresolved adverse reaction to immunotherapy that requires dose modification.
• Patient has received any radiation therapy within 6 weeks prior to study enrollment.
• Patient has leptomeningeal disease or active brain metastases that are not clinically controlled and asymptomatic for at least 14 days following treatment and prior to study enrollment or has residual neurological dysfunction and has not been off corticosteroids for at least seven days prior to study enrollment.
• Patient has an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
• Patient has received systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within seven days prior to study enrollment. Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
• Patient has any history of primary immunodeficiency.
• Patient has any history of organ transplant that requires use of immunosuppressives.
• Patient has clinical signs or symptoms of active tuberculosis infection.
• Patient has history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease.
• Patient has documented evidence of acute hepatitis or has an active or uncontrolled infection.
• Patient has undergone major surgery within 28 days prior to study enrollment or has planned for other major surgery to be performed while enrolled in the clinical trial.

Sponsors & Collaborators

• Galvanize Therapeutics, Inc.: lead

Study Sites (3)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Radboud University Medical Center

Nijmegen, 6500HB, Netherlands

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Related Publications (1)

• Jimenez M, Fernandez JM, Krimsky WS. Pulsed Electric Field (PEF) treatment of progressive non-small cell lung cancer concurrently treated with immune checkpoint blockade: A case report. Respir Med Case Rep. 2024 Mar 29;49:102018. doi: 10.1016/j.rmcr.2024.102018. eCollection 2024.

  PMID: 38601720 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single cohort consecutive case series

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 26, 2021
• Study Start: May 9, 2022
• Primary Completion: February 23, 2023
• Study Completion: April 21, 2023
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); NL (1); HK (1)