A Phase 2 Study Using Aliya Pulsed Electric Field Ablation Plus Pembrolizumab for Sarcoma

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• Objective response(24 months)
• Overall survival(24 months)