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

NCT06128863 | Active Not Recruiting Phase 2

• 2 other identifiers: EFTISARC-NEO/NIO-00042022-003845-36
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neoadjuvant; Immunotherapy; Sarcoma,Soft Tissue; Radiation Therapy

Keywords

soft tissue sarcoma; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Pathologic response

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

  At the time of definitive surgical treatment

Secondary Outcomes (7)

• Number of Participants Experiencing Adverse Events (AEs)

  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).

• Number of participants completing neoadjuvant therapy

  2 years

• Disease-free survival (DFS)

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

• Local recurrence-free survival (LRFS)

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

• Distant metastasis-free survival (DMFS)

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

Study Arms (1)

single arm

OTHER

Systemic therapy with pembrolizumab and eftilagimod alfa is given concurrently with radiotherapy. Surgery is scheduled 5-6 weeks after completion of radiotherapy.

Drug: Pembrolizumab, Eftilagimod alfa

Interventions

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)

Also known as: Keytruda, Eftilagimod alfa, Efti

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Ewing sarcoma, Alveolar and embryonal rhabdomyosarcoma
• Previous treatment with eftilagimod alfa, anti-PD-1 or anti-PD-L1;
• Prior radiotherapy to tumor-involved sites;

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• Immutep S.A.S.: collaborator

Study Sites (1)

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, 00-738, Poland

Location

MeSH Terms

Conditions

Sarcoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Katarzyna Kozak

  Maria Sklodowska-Curie National Research Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2023
• First Posted: November 13, 2023
• Study Start: July 17, 2023
• Primary Completion: April 30, 2025
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-02

Locations

PL (1)