Clinical trial NCT05890872: Aliya™ Pulsed Electric Fields (PEF) for Advanced Cancer
Official title: A Clinical Study of Aliya™ Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment for Advanced Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Neoplasm Malignant
Keywords: Lung Neoplasms
Thoracic Neoplasms
Immunologic Factors
Lead sponsor: Galvanize Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate safety of delivering Aliya PEF in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.

Detailed description: The Aliya Treatment System is designed to deliver therapeutic PEF energy to target tissues, via either a percutaneous or bronchoscopic approach. In order to evaluate the therapeutic potential of PEF delivered via the Aliya Treatment System as an interventional treatment, this clinical trial will evaluate the safety of delivering Aliya PEF in non-surgical advanced stage disease treatment-naïve patients indicated for diagnostic biopsy and first line (1L) standard of care (SOC) therapy. Additionally, this study will examine the safety of adding PEF treatment to the care pathway for patients with metastatic cancer to the lung or stage IV NSCLC and further assess the potential immune modulation and treatment effect of PEF for providing benefit to oncological patients, as outlined below.

Eligibility criteria: Inclusion Criteria:

* Patient has suspected or confirmed metastatic cancer within the lungs, or stage IV non-small cell lung cancer (NSCLC) requiring biopsy.
* Patient has radiologically documented suspected, or confirmed tumor(s) that are ≤ 5 cm in longest diameter and deemed by the investigator to be suitable per study procedural guidelines for treatment with PEF.
* Patient is deemed eligible to receive 1L SOC therapy for their malignancy.
* In the opinion of the investigator, the patient is not a surgical candidate for curative intent, or the patient has refused surgery.
* Life expectancy ≥ 6 months.

Exclusion Criteria:

* Patient has received any prior cancer therapy for current tumor(s) to be treated with PEF.
* Patient is scheduled to receive investigational therapies (including device-based therapy) that may interfere with the study endpoints while on this study.
* Patient has clinical evidence of leptomeningeal disease or brain metastases that require SOC treatment within 4 weeks post-PEF treatment.
* Patient with active, known, or suspected autoimmune disease.
* Patient with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* 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 30 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 clinical signs or symptoms of active tuberculosis infection.
* Patient has documented evidence of acute hepatitis or has an active or uncontrolled infection.
* Patient has undergone major surgery (excluding placement of vascular access) within 28 days prior to study enrollment or has planned major surgeries while enrolled in the study,

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Device and Procedure related serious adverse events
timeFrame: 30 days post PEF
measure: Percentage of subjects whose SOC cancer treatment was not cancelled or postponed
timeFrame: 1 year Post PEF
Secondary outcomes:
measure: Procedural success
timeFrame: Day of procedure
measure: Anesthesia Type Usage
timeFrame: During PEF procedure
measure: PEF Target Location
timeFrame: During PEF procedure
measure: Initiation of first-line (1L) SOC therapy following PEF treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New York
country: United States
facility: Weill Cornell Medicine | New York-Presbyterian
state: New York
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas, Inc.
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Chief Medical Officer
name: William Krimsky, MD
role: STUDY_CHAIR
References: