Study on Pembrolizumab and Eftilagimod Alfa with Radiotherapy for Patients with Resectable Soft Tissue Sarcomas

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What is this study about?

This clinical trial is focused on studying the treatment of soft tissue sarcomas, which are a type of cancer that occurs in the tissues that connect, support, or surround other structures and organs of the body. The study involves a combination of treatments, including a medication called pembrolizumab, known by the brand name Keytruda, and another medication with the code name IMP321, which contains the active substance eftilagimod alfa. These medications are used alongside radiotherapy, a treatment that uses high doses of radiation to kill cancer cells and shrink tumors.

The purpose of this study is to evaluate how effective and safe this combination of treatments is when given before surgery to patients with operable soft tissue sarcomas. Participants in the study will receive these treatments over a period of time before undergoing surgery to remove the tumor. The study aims to observe the response of the tumor to the treatment by examining the tissue after it has been surgically removed.

Throughout the study, researchers will monitor the safety of the treatment and how well patients tolerate it. They will also track the time patients remain free from the disease, the rate of local recurrence, and overall survival. Additionally, the study will explore potential biomarkers, which are biological indicators that might help predict how well a patient responds to the treatment. The study is expected to continue until the end of 2026.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Written informed consent is required to participate.

Eligibility criteria include being 18 years or older, having a performance status of 0 to 1 on the ECOG Performance Scale, and having resectable soft tissue sarcomas.

2 initial assessment

The patient will undergo an initial assessment to confirm the size and location of the tumor using imaging techniques such as CT or MRI.

The disease must be measurable and non-metastatic, with no previous systemic treatment for sarcoma.

3 treatment phase

The treatment involves a combination of pembrolizumab and eftilagimod alfa, administered as a solution for injection and infusion.

Pembrolizumab is provided as a 25 mg/mL concentrate for solution for infusion, and eftilagimod alfa is administered as a solution for injection.

The treatment is combined with preoperative radiotherapy to enhance the pathological response.

4 surgery

After completing the preoperative treatment, the patient will undergo surgery to remove the tumor.

The primary endpoint is to evaluate the pathological response, defined as the percentage of fibrosis and hyalinization in the surgical specimen.

5 follow-up

Post-surgery, the patient will be monitored for treatment safety and efficacy.

Secondary endpoints include disease-free survival time, local recurrence-free survival, distant metastasis-free survival, overall survival, and overall response rate.

Who Can Join the Study?

Willing and able to provide written informed consent for the trial.
Be 18 years of age or older on the day of signing the informed consent.
Have a performance status of 0 to 1 on the ECOG Performance Scale, which means you are fully active or have some symptoms but can still do light work.
Have a primary or locally recurrent soft tissue sarcoma located deep in the arms, legs, shoulder, hip areas, or on the surface of the chest or belly.
The size of the primary tumor should be more than 5 cm as seen in imaging tests like CT or MRI, or it can be any size if it has come back in the same place.
Have a measurable disease based on RECIST 1.1, which means the tumor can be measured in size using specific criteria.
Have non-metastatic disease, meaning the cancer has not spread to other parts of the body.
No previous systemic treatment for sarcoma, which means you haven’t had treatments that affect the whole body, like chemotherapy, for this type of cancer.
Have Grade 2 or 3 tumors according to FNCLCC, which refers to the classification of the tumor based on how abnormal the cancer cells look under a microscope.

Who Cannot Join the Study?

Patients who have a type of cancer that cannot be removed by surgery.
Patients who are not able to receive the specific combination of treatments being studied.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the medications used in the study.
Patients who have an active infection that requires treatment.
Patients who have a history of certain heart problems.
Patients who have a history of certain lung problems.
Patients who have a history of certain liver problems.
Patients who have a history of certain kidney problems.
Patients who have a history of certain immune system problems.
Patients who have a history of certain blood disorders.
Patients who have a history of certain neurological disorders.
Patients who have a history of certain psychiatric disorders.
Patients who have a history of substance abuse.
Patients who are unable to follow the study procedures.
Patients who do not agree to use effective birth control methods during the study.

Where you can join this trial?

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Site Name	City	Country	Status
Ndwzoxqx Ixhjjdpn Ofgqxsvhf Imv Myupn Sjyreaxgnvmtmoexjqtcyygjzeaj Ibtvpeki Bzpjzrjx	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.04.2023

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this trial to help the body’s immune system fight cancer. It works by blocking a specific protein on cancer cells, which allows the immune system to better recognize and attack these cells. In this study, it is being tested in combination with other treatments to see if it can improve outcomes for patients with soft tissue sarcomas.

Eftilagimod Alpha is a soluble protein that is being studied for its potential to enhance the immune response against cancer. It is used in this trial to see if it can work together with pembrolizumab and radiotherapy to improve the treatment of soft tissue sarcomas. The goal is to see if this combination can lead to a better response in the cancer tissue before surgery.

Radiotherapy is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, it is used before surgery to try to shrink the tumor and make it easier to remove. The study is investigating whether combining radiotherapy with pembrolizumab and eftilagimod alpha can lead to better outcomes for patients with soft tissue sarcomas.

Resectable Soft Tissue Sarcomas – Soft tissue sarcomas are a group of cancers that begin in the tissues that connect, support, or surround other structures and organs of the body. These tissues include muscle, fat, blood vessels, nerves, tendons, and the lining of the joints. When these sarcomas are resectable, it means they can be surgically removed. The disease often starts as a painless lump, which may grow over time. As the tumor enlarges, it can press against nerves and muscles, causing pain or discomfort. The progression of the disease depends on the type and location of the sarcoma, as well as how quickly it grows.

Trial ID:

2024-515971-37-00

Protocol code:

EFTISARC-NEO/NIO0004

NCT ID:

NCT06128863

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Pembrolizumab and Eftilagimod Alfa with Radiotherapy for Patients with Resectable Soft Tissue Sarcomas

What is this study about?

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