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NCT Number: NCT06128863

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

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.

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Key information

Conditions

Neoadjuvant Immunotherapy Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Radiation Therapy Sarcoma Sarcoma,Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, 00-738, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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;

Treatment and study plan

Pembrolizumab, Eftilagimod alfa

Drug

Eftilagimod alfa 20 mg s.c. every 2 weeks (5 doses), Pembrolizumab 200 mg i.v. every 3 weeks (3 cycles), Radiotherapy 50 Gy (25 x 2 Gy)

Other names: Keytruda, Eftilagimod alfa, Efti

Primary outcomes

  1. Pathologic response

    Time frame: At the time of definitive surgical treatment

    The primary efficacy endpoint is a percent tumor hyalinization as a marker of response to treatment assessed at the time of surgical resection.

Secondary outcomes

  1. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: All adverse events will be documented from the enrolment of the first patient until 100 days after the surgical treatment of the last patient (2 years).

    Safety analyses will include all patients who received at least one dose of study drug. Safety will be assessed through summaries of adverse events, changes in laboratory test results, changes in vital signs.

    Verbatim description of adverse events will be summarized and graded according to International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. In addition, serious adverse events, severe adverse events (Grades 3, 4, and 5), and adverse events leading to study drug discontinuation or interruption will be summarized accordingly.

  2. Number of participants completing neoadjuvant therapy

    Time frame: 2 years

    Number of patients completing neoadjuvant treatment and having a curative surgery according to the protocol

  3. Disease-free survival (DFS)

    Time frame: From the date of curative surgery to the date of first recurrence or death (whatever the cause), whichever occurs first

    Disease-free survival (DFS) is defined as the time from between the date of curative surgery and the date of disease recurrence defined as clinically diagnosed or biopsy-confirmed recurrent sarcoma at a site of the primary tumor, development of nodal metastasis, locoregional recurrence or distant metastases confirmed by imaging or clinical examination, or death without documented recurrence

  4. Local recurrence-free survival (LRFS)

    Time frame: From the date of curative surgery to the date of first local recurrence or date of death (whatever the cause), whichever occurs first

    Local recurrence-free survival (LRFS) is defined as the time between the date of curative surgery and the date of local recurrence confirmed by imaging or clinical examination. Patients still alive and without signs of disease recurrence at the analysis cut-off date are censored at the last date known to be alive.

  5. Distant metastasis-free survival (DMFS)

    Time frame: From the date of curative surgery to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first

    Distant metastasis-free survival (DMFS) is defined as the time between the date of curative surgery to the date of diagnosis of distant metastases confirmed by imaging or clinical examination. Patients still alive and without signs of distant metastases at the analysis cut-off date are censored at the last date known to be alive.

  6. Overall survival (OS)

    Time frame: From the date of curative surgery up to the date of death or the last date the participant was known to be alive

    Overall survival (OS) is defined as the time between the date of curative surgery and the date of death from any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.

  7. Response rate

    Time frame: From the date of the first dose of treatment to the date of curative surgery

    Radiologic Response To Neoadjuvant Treatment using RECIST 1.1

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Collaborators

  • Immutep S.A.S.

Registry information

Official study title

Phase II, Single-arm Clinical Trial Evaluating Efficacy and Safety of Pembrolizumab in Combination With a Soluble LAG-3 Protein, Eftilagimod Alpha, and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcomas (EFTISARC-NEO)

Acronym: EFTISARC-NEO

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Nov 13, 2023
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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