Clinical trial · Interventional
A Phase 2 Study Using Aliya PEF Plus Pembro for Sarcoma
A Phase 2 Study Using Aliya Pulsed Electric Field Ablation Plus Pembrolizumab for Sarcoma
NCT06494787CI-TRIAL-00086397SOC-2320withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aliya Pulse Electric Field sysem and pembrolizumab | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aliya PEF Plus Pembrolizumab
- description
- This is an open label, phase 2 using Aliya PEF energy and Pembrolizumab 200 mg i.v. over 30 minutes every 3 weeks.
- interventionNames
- Combination Product: Aliya Pulse Electric Field sysem and pembrolizumab
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 24 months
- description
- Progression free survival at 6 months
Secondary outcomes (2)
- measure
- Objective response
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTChen 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. PMID 25928327
- RESULTJimenez 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
- RESULTJ. 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