Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial
Pembrolizumab, Eftilagimod alfa: 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)
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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;
Primary outcome measure(s)
Pathologic response — 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.
Trial sites (1)
Facility
City
Region
Status
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw
Poland
More Maria Sklodowska-Curie National Research Institute of Oncology trials in Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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