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Study on Pembrolizumab and Radiotherapy for Patients with High-Risk Soft Tissue Sarcoma in the Limbs

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called high-risk soft tissue sarcoma that occurs in the arms or legs. This includes specific subtypes like undifferentiated pleomorphic sarcoma and dedifferentiated/pleomorphic liposarcoma. The study is investigating a treatment involving a medication called pembrolizumab, which is also known by the brand name KEYTRUDA. Pembrolizumab is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to see if using pembrolizumab along with radiotherapy before surgery, and continuing with pembrolizumab after surgery, can help improve the time patients remain free from the disease compared to using only radiotherapy before surgery. The study involves two groups of patients: one group will receive pembrolizumab with radiotherapy before surgery and continue with pembrolizumab after surgery, while the other group will receive only radiotherapy before surgery. The study aims to assess the safety and effectiveness of pembrolizumab in treating this type of cancer.

Participants in the study will undergo a series of treatments and follow-ups over a period of time. The study will monitor how well the treatment works in preventing the cancer from coming back and will also look at the overall survival of the patients. The study is expected to continue until 2028, providing valuable information on the potential benefits of pembrolizumab for patients with high-risk soft tissue sarcoma of the extremity.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, imaging tests, and laboratory tests to ensure the presence of a high-risk soft tissue sarcoma of the extremity.

    Eligibility criteria include being 12 years or older, having a tumor size greater than 5 cm, and having adequate organ function. A negative pregnancy test is required for women of childbearing potential.

  2. Step 2

    Treatment group assignment

    Participants are randomly assigned to one of two groups. The first group receives neoadjuvant pembrolizumab with radiotherapy, followed by surgery and adjuvant pembrolizumab. The second group receives radiotherapy followed by surgery.

  3. Step 3

    Neoadjuvant treatment

    For those in the first group, pembrolizumab is administered as an intravenous infusion. The dosage is 200 mg every three weeks, combined with radiotherapy targeting the tumor.

    This phase aims to reduce the tumor size before surgical removal.

  4. Step 4

    Surgical resection

    Surgery is performed to remove the tumor. This step is crucial for both groups and is scheduled after the completion of the neoadjuvant treatment phase.

  5. Step 5

    Adjuvant treatment

    Participants in the first group receive additional pembrolizumab infusions post-surgery. The dosage remains 200 mg every three weeks, continuing for up to one year or until disease progression.

  6. Step 6

    Follow-up and monitoring

    Regular follow-up visits are scheduled to monitor health status and detect any signs of disease recurrence. These visits include physical examinations, imaging tests, and laboratory tests.

    The primary goal is to assess disease-free survival, with secondary evaluations of recurrence-free survival and overall survival.

Who can join the trial?

15 criteria

  • Must be **12 years or older**.
  • Must have a confirmed diagnosis of a specific type of **soft tissue sarcoma** in the arms or legs. This includes certain types of tumors that are larger than 5 cm.
  • Can have certain other types of cancer, like non-melanoma skin cancer, early-stage prostate cancer, or in situ carcinoma.
  • Must have an **ECOG Performance Status** of 0 or 1, which means being fully active or having some symptoms but still able to do light work.
  • The primary tumor must be **resectable**, meaning it can be surgically removed, and there should be no signs of cancer spreading to other parts of the body.
  • Must have **adequate organ function**, which includes:
    • Enough **neutrophils**, a type of white blood cell, to fight infection.
    • Enough **platelets** to help with blood clotting.
    • Enough **hemoglobin** in the blood, which carries oxygen.
    • Normal **kidney function**, measured by creatinine levels.
    • Normal levels of **liver enzymes** (ALT and AST).
    • Normal **bilirubin** levels, which is a substance made by the liver.
    • Enough **albumin**, a protein in the blood.
    • Must provide **written, voluntary informed consent** to participate in the study.
    • Men and women who can have children must agree to use **effective birth control** during the study and for 120 days after the last dose of the study drug.
    • Women who can have children must have a **negative pregnancy test** within 72 hours before starting the study.

Who cannot join the trial?

9 criteria

  • Patients with a different type of cancer than the one being studied cannot participate.
  • Patients with a tumor size less than or equal to 5 cm cannot participate.
  • Patients with a tumor grade lower than 2 out of 3 cannot participate. Tumor grade refers to how much the cancer cells look like normal cells under a microscope. A higher grade means the cells look less like normal cells and may grow or spread more quickly.
  • Patients who are not able to undergo surgery cannot participate.
  • Patients who cannot receive radiotherapy cannot participate. Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells or shrink tumors.
  • Patients who cannot receive pembrolizumab cannot participate. Pembrolizumab is a type of medication used to help the immune system fight cancer.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with certain medical conditions that might interfere with the study cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this trial to help the body's immune system fight cancer. It is given to patients before and after surgery to see if it can improve the chances of the cancer not coming back. Pembrolizumab works by blocking a specific protein that prevents the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

  • Radiotherapy

    is a treatment that uses high-energy rays to kill cancer cells. In this trial, it is used before surgery to shrink the tumor and make it easier to remove. The goal is to see if combining radiotherapy with pembrolizumab before surgery can improve the outcomes for patients with high-risk soft tissue sarcoma.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently well-established in medical literature as an immunotherapy drug used to treat various types of cancer. The main therapeutic indication for pembrolizumab in this trial is high-risk soft tissue sarcoma of the extremity, specifically undifferentiated pleomorphic sarcoma or dedifferentiated/pleomorphic liposarcoma. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified pharmacologically as a monoclonal antibody and immune checkpoint inhibitor.

Investigated diseases

  • Undifferentiated Pleomorphic Sarcoma

    This is a type of soft tissue sarcoma that typically occurs in the extremities, such as arms or legs. It is characterized by a mix of different cell types that appear disorganized under a microscope. The disease often presents as a large, painless mass that can grow rapidly. As it progresses, it may invade nearby tissues and has the potential to spread to other parts of the body. The tumor is usually graded based on its appearance and growth rate, with higher grades indicating more aggressive behavior.

  • Dedifferentiated Liposarcoma

    This is a subtype of liposarcoma, a cancer that arises in fat cells, and is known for its aggressive nature. It typically starts as a well-differentiated liposarcoma and then transforms into a more aggressive form. The tumor often appears as a large mass in the extremities and can grow quickly. As it progresses, it may invade surrounding tissues and has the potential to metastasize to distant sites. The disease is graded based on the degree of cellular abnormality and growth rate, with higher grades indicating a more aggressive form.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517858-10-00Protocol codeSU2C-SARC032Estimated enrolment110 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).