Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunotherapy | — | UNRESOLVED | — |
| Neoadjuvant | — | UNRESOLVED | — |
| Radiation Therapy | — | UNRESOLVED | — |
| Sarcoma,Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab, Eftilagimod alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- single arm
- description
- Systemic therapy with pembrolizumab and eftilagimod alfa is given concurrently with radiotherapy. Surgery is scheduled 5-6 weeks after completion of radiotherapy.
- interventionNames
- Drug: Pembrolizumab, Eftilagimod alfa
Primary outcomes (1)
- measure
- Pathologic response
- timeFrame
- At the time of definitive surgical treatment
- description
- 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 (7)
- measure
- Number of Participants Experiencing Adverse Events (AEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available