Clinical trial NCT06494787: A Phase 2 Study Using Aliya PEF Plus Pembro for Sarcoma
Official title: A Phase 2 Study Using Aliya Pulsed Electric Field Ablation Plus Pembrolizumab for Sarcoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Lead sponsor: Sarcoma Oncology Research Center, LLC
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

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.

Primary outcomes:
measure: Progression free survival
timeFrame: 24 months
Secondary outcomes:
measure: Objective response
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Sarcoma Oncology Research Center
name: Sant Chawla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sarcoma Oncology Research Center
name: Neal Chawla, MD
role: STUDY_DIRECTOR
References:
citation: Chen X, Ren Z, Li C, Guo F, Zhou D, Jiang J, Chen X, Sun J, Yao C, Zheng S. Preclinical Study of Locoregional Therapy of Hepatocellular Carcinoma by Bioelectric Ablation with Microsecond Pulsed Electric Fields (musPEFs). Sci Rep. 2015 Apr 30;5:9851. doi: 10.1038/srep09851.
citation: Jimenez M, Ng C, Iding J, et al. Single-Needle Delivery of Pulsed Electric Fields (PEF) Energy to Early-Stage Non- Small Cell Lung Cancer (NSCLC): Feasibility and Safety Near Sensitive Structures in the INCITE ES Study. JVIR. 2023; 34(3):S71-S72
citation: J. lding, P. Vanderlaan, M. Jimenez, J. Fernandez Garcia-Hierro, J. Flandes Aldeyturriaga, E. van der Heijden, C. Ng, R. Lau, M. Ludena, R. Carias, M. Cedeno, A. Moreno-Gonzalez, B. Hatton, W. Krimsky. Tertiary lymphoid structures (TLS) observed in non-small cell lung cancer (NSCLC) tumors treated with Pulsed Electric Fields. Journal for Immunotherapy of Cancer 2022;10(Suppl 2):Al-A1595