Status:
WITHDRAWN
A Phase 2 Study Using Aliya PEF Plus Pembro for Sarcoma
Lead Sponsor:
Sarcoma Oncology Research Center, LLC
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 subject...
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 Sys...
Eligibility Criteria
Inclusion
- 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
- Patients with untreated CNS disease
- Anticancer therapy within 2 weeks
- Concurrent immunotherapy
- Pregnant women
- Autoimmune disorder
- Severe or uncontrolled systemic disease.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06494787
Start Date
August 1 2024
End Date
December 31 2025
Last Update
February 24 2025
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