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Trial Title:
Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial
NCT ID:
NCT06128863
Condition:
Neoadjuvant
Immunotherapy
Sarcoma,Soft Tissue
Radiation Therapy
Conditions: Official terms:
Sarcoma
Pembrolizumab
Conditions: Keywords:
soft tissue sarcoma
immunotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pembrolizumab, Eftilagimod alpha
Description:
Eftilagimod alpha 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)
Arm group label:
single arm
Other name:
Keytruda
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 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.
Detailed 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.
Criteria for eligibility:
Criteria:
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:
1. undifferentiated pleomorphic sarcoma (UPS),
2. myxofibrosarcoma,
3. dedifferentiated liposarcoma (DDLPS),
4. myxoid and round cell liposarcoma (MRCLPS),
5. epithelioid sarcoma (ES),
6. angiosarcoma (AS)
7. 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Maria Sklodowska-Curie National Research Institute of Oncology
Address:
City:
Warsaw
Zip:
00-738
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Pawel Sobczuk
Phone:
+48225462031
Contact backup:
Last name:
Katarzyna Kozak
Phone:
+48225462051
Start date:
July 17, 2023
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Maria Sklodowska-Curie National Research Institute of Oncology
Agency class:
Other
Collaborator:
Agency:
Immutep S.A.S.
Agency class:
Industry
Source:
Maria Sklodowska-Curie National Research Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06128863
