Resectable soft tissue sarcomas MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: EFTILAGIMOD ALPHA
Product Code: IMP321
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Eftilagimod alfa
CAS Number: 1800476-36-1
Current Sponsor code: IMP321
Other descr
Sponsors
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie – Panstwowy Instytut Badawczy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Willing and able to provide written informed consent for the trial. -Be = 18 years of age on day of signing informed consent. -Performance status of 0 to 1 on the ECOG Performance Scale. -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 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. -No previous systemic treatment for sarcoma. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Ewing sarcoma, Alveolar and embryonal rhabdomyoarcoma. -Previous treatment with eftilagimod alpha, anty-PD-1 or ant-PD-L1. -Prior radiotherapy to tumor-involved sites. -Subjects with active, known or suspected autoimmune disease or inflammatory bowel disease, which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatment. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring replacement therapy, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. -A concomitant disease that, in the opinion of the investigator, poses an unacceptable risk to the patient if he or she participates in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy of pembrolizumab and eftilagimod alfa in combination with preoperative radiotherapy in patients with resectable soft tissue sarcomas by analyzing the pathological response in the postoperative material.;Secondary Objective: Secondary Objectives: • assessment of the pathological response according to EORTC-STBSG criteria • assessment of radiological response according to RECIST 1.1 criteria • assessment of disease-free survival (DFS), local relapse-free survival (LRFS) and distant metastasis free survival (DMFS) and overall survival (OS) • evaluation of the safety of the combination of pembrolizumab with eftilagimod alfa • assessment of patients' quality of life (EORTC QLQ-C30 scale and FACT- G);Primary end point(s): The primary endpoint of the study is the pathological response, defined as percentage of fibrosis and hyalinization found in the surgical specimen after completion of preoperative treatment.;Timepoint(s) of evaluation of this end point: Histopathological examination of the excised tumor - resection in the 11th - 12th week of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Treatment safety profile. -Number of patients completing neoadjuvant treatment and having a curative surgery according to the protocol. -Disease-free survival time (DFS) - Local recurrence-free survival (LRFS) - Distant metastasis-free survival (DMFS) - Overall survival (OS) -Overall response rate (ORR) by RECIST 1.1 criteria. -Exploratory endpoints include the search for biomarkers and correlations between their occurrence and response to treatment.;Timepoint(s) of evaluation of this end point: Adverse reactions - on every visit. Survival based on imaging studies performed every 12 weeks. | — |
Countries
Poland
Contacts
Public ContactKatarzyna Kozak
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (NIO-PIB)
Outcome results
None listed