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

• Status: Recruiting
• Trial end date: 2027-04-30
• Target enrollment: 0
• Participant gender: All

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 alpha (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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborator: Immutep S.A.S.
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) tumor;

• One of the following histologies as defined in the World Health Organization (WHO) Classification of Soft Tissue Tumors:

1. undifferentiated pleomorphic sarcoma (UPS),

2. myxofibrosarcoma,

3. dedifferentiated liposarcoma (DDLPS),

4. myxoid and round cell liposarcoma (MRCLPS),

5. epithelioid sarcoma (ES),

6. angiosarcoma (AS)

7. soft tissue sarcoma not otherwise specified (NOS).

• 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 Criteria:

• Previous treatment with eftilagimod alpha, anti-PD-1 or anti-PD-L1;

• Prior radiotherapy to tumor-involved sites;