Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial

Number of Participants Experiencing Adverse Events (AEs)

Safety analyses will include all patients who received at least one dose of study drug. Safety will be assessed through summaries of adverse events, changes in laboratory test results, changes in vital signs. Verbatim description of adverse events will be summarized and graded according to International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. In addition, serious adverse events, severe adverse events (Grades 3, 4, and 5), and adverse events leading to study drug discontinuation or interruption will be summarized accordingly.

Time frame: 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).

Number of participants completing neoadjuvant therapy

Number of patients completing neoadjuvant treatment and having a curative surgery according to the protocol

Time frame: 2 years

Disease-free survival (DFS)

Disease-free survival (DFS) is defined as the time from between the date of curative surgery and the date of disease recurrence defined as clinically diagnosed or biopsy-confirmed recurrent sarcoma at a site of the primary tumor, development of nodal metastasis, locoregional recurrence or distant metastases confirmed by imaging or clinical examination, or death without documented recurrence

Time frame: 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)

Local recurrence-free survival (LRFS) is defined as the time between the date of curative surgery and the date of local recurrence confirmed by imaging or clinical examination. Patients still alive and without signs of disease recurrence at the analysis cut-off date are censored at the last date known to be alive.

Time frame: From the date of curative surgery to the date of first local recurrence or date of death (whatever the cause), whichever occurs first

Distant metastasis-free survival (DMFS)

Distant metastasis-free survival (DMFS) is defined as the time between the date of curative surgery to the date of diagnosis of distant metastases confirmed by imaging or clinical examination. Patients still alive and without signs of distant metastases at the analysis cut-off date are censored at the last date known to be alive.

Time frame: 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)

Overall survival (OS) is defined as the time between the date of curative surgery and the date of death from any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.

Time frame: 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

Radiologic Response To Neoadjuvant Treatment using RECIST 1.1

Time frame: From the date of the first dose of treatment to the date of curative surgery