A Phase 2 Study Using Aliya PEF Plus Pembro for Sarcoma

Trial Title: A Phase 2 Study Using Aliya PEF Plus Pembro for Sarcoma

NCT ID: NCT06494787

Condition: Soft Tissue Sarcoma

Conditions: Official terms:
Sarcoma
Pembrolizumab

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: This is a phase 2 study to determine the efficacy and safety of the Aliya PEF System combined with pembrolizumab in treating patients with advanced soft tissue sarcoma.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Combination Product
Intervention name: Aliya Pulse Electric Field sysem and pembrolizumab
Description: This is a phase 2 study to determine the efficacy of the Aliya Pulse Electric Field system and pembrolizumab in prolonging progression free and overall survival of patients with advanced soft tissue sarcoma
Arm group label: Aliya PEF Plus Pembrolizumab

Summary: 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.

Detailed 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Start date: August 1, 2024

Completion date: December 31, 2025

Lead sponsor:
Agency: Sarcoma Oncology Research Center, LLC
Agency class: Other

Source: Sarcoma Oncology Research Center, LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06494787