Soft Tissue Sarcoma
Conditions
Brief 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.
Interventions
COMBINATION_PRODUCTAliya Pulse Electric Field sysem and pembrolizumab
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
Sponsors
Sarcoma Oncology Research Center, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 24 months | Progression free survival at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response | 24 months | • Objective response rate by RECIST v1.1 and iRECIST via CT scan or MRI after every 6-weeks |
| Overall survival | 24 months | Overall survival at 6, 9, 12, 24 months |
Outcome results
None listed