Status:
ACTIVE_NOT_RECRUITING
Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborating Sponsors:
Immutep S.A.S.
Conditions:
Neoadjuvant
Immunotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 tr...
Detailed Description
Systemic therapy with pembrolizumab and eftilagimod alfa and radiotherapy are administered concurrently. Systemic treatment lasts for 9 weeks (study week 1-9). Radiation therapy lasts for 5 weeks (5 d...
Eligibility Criteria
Inclusion
- Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) soft tissue sarcoma
- Grade 2 or 3 tumors according to Fédération Nationale des Centres de Lutte contre le Cancer (FNCLCC);
- Size of the primary tumor \>5 cm at instrumental staging (CT, MRI), or locally recurrent of any size;
- Measurable disease based on RECIST 1.1;
- Non-metastatic disease;
Exclusion
- Ewing sarcoma, Alveolar and embryonal rhabdomyosarcoma
- Previous treatment with eftilagimod alfa, anti-PD-1 or anti-PD-L1;
- Prior radiotherapy to tumor-involved sites;
Key Trial Info
Start Date :
July 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06128863
Start Date
July 17 2023
End Date
April 30 2027
Last Update
December 8 2025
Active Locations (1)
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1
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland, 00-738