Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494787
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
A Phase 2 Study Using Aliya PEF Plus Pembro for Sarcoma
Sponsor:
Sarcoma Oncology Research Center LLC
Organization:
Sarcoma Oncology Research Center LLC
Study Overview
Official Title:
A Phase 2 Study Using Aliya Pulsed Electric Field Ablation Plus Pembrolizumab for Sarcoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOC-2320
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 inhibitorin 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 etcBoth Aliya and Pembrolizumab are FDA approved products
ObjectivesPrimary o evaluate progression free survival at 6 months Secondary To evaluate the objective response rate by RECIST v11 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 v11 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 quantitiesThe population to be studied include male and female subjects 18 years of age or older of any ethnicity with 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 etcBoth Aliya and Pembrolizumab are FDA approved products
ObjectivesPrimary o evaluate progression free survival at 6 months Secondary To evaluate the objective response rate by RECIST v11 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 v11 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 quantitiesThe population to be studied include male and female subjects 18 years of age or older of any ethnicity with advanced soft tissue sarcoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None