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)

Maria Sklodowska-Curie National Research Institute of Oncology1 site in 1 country40 target enrollmentJuly 17, 2023

ConditionsNeoadjuvant Immunotherapy Sarcoma,Soft Tissue Radiation Therapy

InterventionsPembrolizumab, Eftilagimod alfa

Overview

Phase: Phase 2
Intervention: Pembrolizumab, Eftilagimod alfa
Conditions: Neoadjuvant
Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Enrollment: 40
Locations: 1
Primary Endpoint: Pathologic response
Status: Active, not recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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 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.

Detailed Description

Systemic therapy with pembrolizumab and eftilagimod alfa 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.

Registry

clinicaltrials.gov

Start Date

July 17, 2023

End Date

April 30, 2027

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Responsible Party

Sponsor

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 \>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;

Arms & Interventions

single arm

Systemic therapy with pembrolizumab and eftilagimod alfa is given concurrently with radiotherapy. Surgery is scheduled 5-6 weeks after completion of radiotherapy.

Intervention: Pembrolizumab, Eftilagimod alfa

Outcomes

Primary Outcomes

Pathologic response

Time Frame: 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.

Secondary Outcomes

Number of Participants Experiencing Adverse Events (AEs)(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).)
Distant metastasis-free survival (DMFS)(From the date of curative surgery to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first)
Overall survival (OS)(From the date of curative surgery up to the date of death or the last date the participant was known to be alive)
Response rate(From the date of the first dose of treatment to the date of curative surgery)
Number of participants completing neoadjuvant therapy(2 years)
Disease-free survival (DFS)(From the date of curative surgery to the date of first recurrence or death (whatever the cause), whichever occurs first)
Local recurrence-free survival (LRFS)(From the date of curative surgery to the date of first local recurrence or date of death (whatever the cause), whichever occurs first)