NCT06128863Active, not recruitingPhase 2
Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial
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)
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 28 Oct 2023
- Start date
- 17 Jul 2023
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Diseases
- Sarcoma
- NCT number
- NCT06128863
- EudraCT number
- 2022-003845-36
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 17 Jul 2023 to the primary completion date, 30 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with eftilagimod alfa, anti-PD-1 or anti-PD-L1;
- Prior radiotherapy to tumor-involved sites;
Other
- Ewing sarcoma, Alveolar and embryonal rhabdomyosarcoma
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maria Sklodowska-Curie - National Research Institute of Oncology Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.