A Phase 2 Study Using Aliya PEF Plus Pembro for Sarcoma (SOC-2320)

Sarcoma Oncology Research Center, LLC

Status and phase: Withdrawn; Phase 2

Conditions: Soft Tissue Sarcoma

Treatments: Combination Product: Aliya Pulse Electric Field sysem and pembrolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06494787

SOC-2320

Details and patient eligibility

About

The is a phase 2 that will evaluate the efficacy and safety of the Aliya PEF ablation system combined with pembrolizumab, an immune checkpoint inhibitor.in advanced soft tissue sarcoma. Twenty subjects will be treated.

Full description

This is a Phase 2 study that will evaluate the efficacy and safety of the Aliya PEF ablation system plus pembrolizumab, an immune checkpoint inhibitor in advanced soft tissue sarcoma.

The AliyaTM System (Galvanize TherapeuticsTM) is a biphasic monopolar pulsed electric field (PEF) system that induces cell death in a manner independent of thermal processes, enabling focal ablation without denaturing stromal proteins or inducing significant muscle contraction. Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking indicated for various malignancies including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, etc.Both Aliya and Pembrolizumab are FDA approved products.

Objectives:Primary: o evaluate progression free survival at 6 months; Secondary: To evaluate the objective response rate by RECIST v1.1 via CT scan or MRI at week 6 and every 6 weeks thereafter until end of treatment (EOT); to determine progression-free survival (PFS) at 6 months and overall survival, and to evaluate the incidence and grade of treatment related adverse events.

Exploratory: To evaluate PEF-Treated Dose-Response- Pre-PEF and follow-up as per standard of care after PEF energy delivery by RECIST v1.1 and iRECIST criteria, and to conduct biomarker analyses performed on tumor homogenate prep (THP) and lab blood draws collected at follow-up visits as per standard of care, which may include flow cytometry analyses of cell populations, cytokines, tumor-specific T-cell and B-cell populations, and tumor-specific IgG antibody quantities.The population to be studied include male and female subjects 18 years of age or older, of any ethnicity, with advanced soft tissue sarcoma.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female ≥ 18 years of age
• Pathologically confirmed diagnosis of pleomorphic sarcoma, myxofibrosarcoma, leiomyosarcoma, liposarcoma, synovial sarcoma
• Previously treated or untreated patients
• Measurable disease with at least one target lesion amenable to PEF
• Life expectancy at least 3 months
• Adequate hematologic, liver and kidney function
• ECOG performance status of 0-1
• Willingness to sign informed consent
• Negative pregnancy test if female

Exclusion criteria

• Patients with untreated CNS disease
• Anticancer therapy within 2 weeks
• Concurrent immunotherapy
• Pregnant women
• Autoimmune disorder
• Severe or uncontrolled systemic disease.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Aliya PEF Plus Pembrolizumab

Experimental group

Description:

This is an open label, phase 2 using Aliya PEF energy and Pembrolizumab 200 mg i.v. over 30 minutes every 3 weeks.

Treatment:

Combination Product: Aliya Pulse Electric Field sysem and pembrolizumab