Soft Tissue SarcomaPhase 2SOC-2320NCT06494787
A Phase 2 Study Using Aliya PEF Plus Pembro for Sarcoma
A Phase 2 study testing Aliya Pulse Electric Field sysem and pembrolizumab in people with Soft Tissue Sarcoma, run by Sarcoma Oncology Research Center, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Aliya Pulse Electric Field sysem and pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- ECOG performance status of 0-1
- Willingness to sign informed consent
- Negative pregnancy test if female
Who cannot join
- Patients with untreated CNS disease
- Anticancer therapy within 2 weeks
- Concurrent immunotherapy
- Pregnant women
- Autoimmune disorder
- Severe or uncontrolled systemic disease.
About this study
Official title: A Phase 2 Study Using Aliya Pulsed Electric Field Ablation Plus Pembrolizumab for Sarcoma
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.
Read the 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.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Aliya Pulse Electric Field sysem and pembrolizumab
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliya Pulse Electric Field sysem and pembrolizumabCombination product
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
| Study group | Role | What they receive |
|---|---|---|
| Aliya PEF Plus Pembrolizumab | Experimental | This is an open label, phase 2 using Aliya PEF energy and Pembrolizumab 200 mg i.v. over 30 minutes every 3 weeks. Receives: Combination Product: Aliya Pulse Electric Field sysem and pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival at 6 months
Measured: 24 months
Secondary outcomes (2)
Objective response
- Objective response rate by RECIST v1.1 and iRECIST via CT scan or MRI after every 6-weeks
Measured: 24 months
Overall survival
Overall survival at 6, 9, 12, 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarcoma Oncology Research Center, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sant Chawla, MD, Principal investigator, Sarcoma Oncology Research CenterNeal Chawla, MD, Study director, Sarcoma Oncology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494787
- Sponsor's protocol ID
- SOC-2320
- Acronym
- SOC-2320
- Status last verified
- Feb 2025
- First submitted
- 2 Jul 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data will remain confidential until final publication of results.
Publications
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.
PubMed 25928327Jimenez 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
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Using Aliya Pulsed Electric Field Ablation Plus Pembrolizumab for Sarcoma
- ClinicalTrials.gov ID
- NCT06494787
- Acronym / sponsor ID
- SOC-2320 / SOC-2320
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sarcoma Oncology Research Center, LLCUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aliya PEF Plus Pembrolizumab | Experimental | Combination Product: Aliya Pulse Electric Field sysem and pembrolizumabThis is an open label, phase 2 using Aliya PEF energy and Pembrolizumab 200 mg i.v. over 30 minutes every 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with untreated CNS disease
- Anticancer therapy within 2 weeks
- Concurrent immunotherapy
- Pregnant women
- Autoimmune disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aliya Pulse Electric Field sysem and pembrolizumabThis 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 | Combination product | Aliya PEF Plus Pembrolizumab |
Primary outcome
Progression free survival
Time frame: 24 months
Progression free survival at 6 months
2 secondary outcomes
Objective response
Time frame: 24 months
Overall survival
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Results publication: PubMed 25928327Chen 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.
- Results publicationJimenez 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
- Results publicationJ. 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
- Individual participant dataSharing planned: No. The study data will remain confidential until final publication of results.
Related trials for Soft Tissue Sarcoma
RecruitingPhase 2
Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma
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Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
Active, not recruitingPhase 1
A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions
Leiomyosarcoma, Soft-tissue Sarcomas
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sant Chawla, MD principal investigator
Sarcoma Oncology Research Center
Neal Chawla, MD study director
Sarcoma Oncology Research Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aliya Pulse Electric Field sysem and pembrolizumab in people with Soft Tissue Sarcoma, run by Sarcoma Oncology Research Center, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06494787, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025; AzTrials last refreshed its copy on 3 Nov 2026.