drugset / Trial / NCT06128863
Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial
Phase 2
Active not recruiting
40 enrolled
Maria Sklodowska-Curie National Research Institute of Oncology
Immutep S.A.S. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-07-17
- Primary completion
- 2025-04-30
- Completion
- 2027-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eftilagimod Alfa | Protein / enzyme biologic | 20 mg | Subcutaneous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |