Overview
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 alpha (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.
Description
Systemic therapy with pembrolizumab and eftilagimod alpha and radiotherapy are administered concurrently. Systemic treatment lasts for 9 weeks (study week 1-9). Radiation therapy lasts for 5 weeks (5 days per week) in weeks 2-6. Surgery takes place 5-6 weeks after completion of radiation therapy (week 11-12). Any adjuvant treatment (chemotherapy, immunotherapy, radiation therapy) after surgical treatment is not allowed. Patients will be then followed up regularly for a period of 24 months.
Eligibility
Inclusion Criteria:
- Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) tumor;
- One of the following histologies as defined in the World Health Organization (WHO)
Classification of Soft Tissue Tumors:
- undifferentiated pleomorphic sarcoma (UPS),
- myxofibrosarcoma,
- dedifferentiated liposarcoma (DDLPS),
- myxoid and round cell liposarcoma (MRCLPS),
- epithelioid sarcoma (ES),
- angiosarcoma (AS)
- soft tissue sarcoma not otherwise specified (NOS).
- 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:
- Previous treatment with eftilagimod alpha, anti-PD-1 or anti-PD-L1;
- Prior radiotherapy to tumor-involved sites;
