PEMBROLIZUMAB for Resectable soft tissue sarcoma

Inclusion criteria

• {"criterion_text":"- Willing and able to provide written informed consent for the trial.\n- Be ≥ 18 years of age on day of signing informed consent.\n- Performance status of 0 to 1 on the ECOG Performance Scale.\n- Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) soft tissue sarcoma\n- Size of the primary tumor >5 cm at instrumental staging (CT, MRI), or locally recurrent of any size\n- Measurable disease based on RECIST 1.1\n- Non-metastatic disease.\n- No previous systemic treatment for sarcoma.\n- Grade 2 or 3 tumors according FNCLCC."}

Exclusion criteria

• {"criterion_text":"- Ewing sarcoma, Alveolar and embryonal rhabdomyoarcoma\n- Previous treatment with eftilagimod alpha, anty-PD-1 or ant-PD-L1.\n- Prior radiotherapy to tumor-involved sites.\n- 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\n- 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"}

Primary endpoints

• {"endpoint_text":"- The pathological response, defined as percentage of fibrosis and hyalinization found in the surgical specimen after completion of preoperative treatment.","definition_or_measurement_approach":"Defined as percentage of fibrosis and hyalinization found in the surgical specimen after completion of preoperative treatment."}

Secondary endpoints

• {"endpoint_text":"- Treatment safety profile\n- Number of patients completing neoadjuvant treatment and having a curative surgery according to the protocol.\n- Disease-free survival time (DFS)\n- Local recurrence-free survival (LRFS)\n- Distant metastasis-free survival (DMFS)\n- Overall survival (OS)\n- Overall response rate (ORR) by RECIST 1.1 criteria\n- Exploratory endpoints include the search for biomarkers and correlations between their occurrence and response to treatment","definition_or_measurement_approach":"Safety profile assessed by routine safety monitoring; feasibility assessed by number of patients completing neoadjuvant treatment and undergoing protocol-defined curative surgery; DFS, LRFS, DMFS and OS as survival time endpoints; ORR assessed by RECIST 1.1; exploratory endpoints include biomarker searches and correlation analyses."}

Other endpoints

• {"endpoint_text":"- Exploratory endpoints include the search for biomarkers and correlations between their occurrence and response to treatment","definition_or_measurement_approach":"Exploratory biomarker identification and correlation analyses between biomarker occurrence and treatment response (no further measurement detail provided)."}

Poland

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

30-10-2024

Processing Time Days

40

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Contract research organisations

Name

Verum.De Polska Sp. z o.o.

Responsibilities

Sponsor duties codes: 1,12; contact email agb@verumpl.com, phone +48604163945

Third parties

• {"country":"Poland","full_name":"Verum.De Polska Sp. z o.o.","duties_or_roles":"Sponsor duties codes: 1,12 (as recorded in thirdParty sponsorDuties)","organisation_type":"Hospital/Clinic/Other health care facility"}