Clinical trial NCT06128863: Pembrolizumab in Combination with Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients with Soft Tissue Sarcoma - EFTISARC-NEO Trial
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Neoadjuvant
Immunotherapy
Sarcoma,Soft Tissue
Radiation Therapy
Keywords: soft tissue sarcoma
immunotherapy
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Immutep S.A.S.
First posted: 2023-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 \&gt;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 alpha, anti-PD-1 or anti-PD-L1;
* Prior radiotherapy to tumor-involved sites;

Primary outcomes:
measure: Pathologic response
timeFrame: At the time of definitive surgical treatment
Secondary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: All adverse events will be documented from the enrolment of the first patient until 100 days after the surgical treatment of the last patient (2 years).
measure: Number of participants completing neoadjuvant therapy
timeFrame: 2 years
measure: Disease-free survival (DFS)
timeFrame: From the date of curative surgery to the date of first recurrence or death (whatever the cause), whichever occurs first
measure: Local recurrence-free survival (LRFS)
timeFrame: From the date of curative surgery to the date of first local recurrence or date of death (whatever the cause), whichever occurs first
measure: Distant metastasis-free survival (DMFS)
timeFrame: From the date of curative surgery to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first
measure: Overall survival (OS)
timeFrame: From the date of curative surgery up to the date of death or the last date the participant was known to be alive
measure: Response rate
timeFrame: From the date of the first dose of treatment to the date of curative surgery
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie National Research Institute of Oncology
Study officials:
affiliation: Maria Sklodowska-Curie National Research Institute of Oncology
name: Katarzyna Kozak
role: PRINCIPAL_INVESTIGATOR
References: