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

Last updated: December 1, 2025
Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Overall Status: Active - Not Recruiting

Phase

2

Condition

Sarcoma

Chemotherapy

Vaccines

Treatment

Pembrolizumab, Eftilagimod alfa

Pembrolizumab, Eftilagimod alpha

Clinical Study ID

NCT06128863
EFTISARC-NEO/NIO-0004
2022-003845-36
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary or locally recurrent deep-seated extremities, girdles and/or superficialtrunk (thoracic or abdominal wall) soft tissue sarcoma

  • Grade 2 or 3 tumors according to Fédération Nationale des Centres de Lutte contre leCancer (FNCLCC);

  • Size of the primary tumor >5 cm at instrumental staging (CT, MRI), or locallyrecurrent of any size;

  • Measurable disease based on RECIST 1.1;

  • Non-metastatic disease;

Exclusion

Exclusion Criteria:

  • Ewing sarcoma, Alveolar and embryonal rhabdomyosarcoma

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

  • Prior radiotherapy to tumor-involved sites;

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Pembrolizumab, Eftilagimod alfa
Phase: 2
Study Start date:
July 17, 2023
Estimated Completion Date:
April 30, 2027

Study 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 days per week) in weeks 2-6. Surgery takes place 5-6 weeks after completion of radiation therapy (week 11-12). Any adjuvant treatment (chemotherapy, immunotherapy, radiation therapy) after surgical treatment is not allowed. Patients will be then followed up regularly for a period of 24 months.

Connect with a study center

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, 00-738
    Poland

    Site Not Available

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw 756135, 00-738
    Poland

    Site Not Available

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