Clinical Trial

Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial

Study acronym: EFTISARC-NEO
Active, Not Recruiting Phase 2
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Summary
This is a phase II single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alfa (Efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. This study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-11-07; most recent amendment 2025-12-01.
Status change: Recruiting → Active, Not Recruiting 2025-02-05
Trial Details
NCT Number NCT06128863
Lead Sponsor Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators: Immutep S.A.S.
Conditions Neoadjuvant, Immunotherapy, Sarcoma,Soft Tissue, Radiation Therapy
Enrollment 40 participants
Start Date 2023-07-17
Primary Completion 2025-04-30 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-08