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Study of Bintrafusp Alfa and Doxorubicin Hydrochloride for Adults with Advanced Soft-Tissue Sarcoma

Verified siteRegistered drugNo placebo
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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 treating patients with , a type of cancer that affects the body's soft tissues. The study involves two treatments: and . is a medication that works by targeting specific proteins involved in cancer growth, while is a well-known chemotherapy drug used to kill cancer cells.

The purpose of the study is to evaluate how effective the combination of these two treatments is in controlling the disease. Patients participating in the trial will receive these medications through an intravenous infusion, which means the drugs are administered directly into the bloodstream. The study will monitor patients over a period to see how their cancer responds to the treatment.

Throughout the trial, patients will undergo regular assessments to track the progress of their disease. These assessments will help determine if the cancer is shrinking, staying the same, or growing. The study aims to provide valuable information on whether this combination of treatments can help manage more effectively. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be required to sign a consent form, confirming your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes a review of your medical history and a series of tests to ensure you meet the trial's criteria.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive two medications: bintrafusp alfa and doxorubicin hydrochloride. Both medications will be administered through an intravenous infusion, which means they will be given directly into your vein.

    Bintrafusp alfa is a concentrate for solution for infusion, and doxorubicin hydrochloride is a solution for infusion. The specific dosage and frequency will be determined by the medical team based on your individual needs and the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, your health and response to the treatment will be closely monitored. Regular check-ups and tests will be conducted to assess the effectiveness of the treatment and to identify any side effects.

    Your progress will be evaluated using criteria known as RECIST v1.1, which helps in measuring how well the treatment is working.

  5. Step 5

    End of treatment

    At the end of the treatment phase, a final assessment will be conducted to evaluate the overall response to the treatment. This includes determining the duration of response and any progression of the disease.

    You will be informed about the results and any further steps that may be necessary.

Who can join the trial?

22 criteria

  • Must be an adult aged 18 years or older.
  • Must have a type of cancer called soft-tissue sarcoma that is either advanced or cannot be removed by surgery.
  • Cancer must be confirmed by a special review process.
  • Must have good blood, kidney, liver, and metabolic function. This includes:
    • Hemoglobin (a protein in red blood cells) level of at least 9 g/dl.
    • Enough white blood cells and platelets.
    • Liver enzymes and other liver function tests within acceptable limits.
    • Normal levels of bilirubin (a substance made by the liver).
    • Albumin (a protein in the blood) level of at least 30 g/l.
    • Normal kidney function or creatinine clearance (a measure of kidney function) of at least 40 ml/min.
    • Normal blood clotting tests.
    • Women who can have children must have a negative pregnancy test before starting the study.
    • Both men and women must agree to use effective birth control during the study and for a period after the study ends.
    • No other cancer diagnosed or treated in the last 3 years, except for certain types that are not serious.
    • Must have recovered from any side effects of previous treatments to a certain level, except for hair loss and mild nerve damage.
    • Must have signed a consent form agreeing to participate in the study.
    • Must have a type of cancer that is either metastatic (spread to other parts of the body) or cannot be removed by surgery.
    • No previous treatment with drugs for advanced or metastatic cancer.
    • Must provide a tumor sample for research purposes.
    • Must have a life expectancy of more than 3 months.
    • Must have a measurable disease, meaning the cancer can be measured using a scan.
    • Must be willing to have tumor biopsies taken for research.
    • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.

Who cannot join the trial?

12 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have had another cancer treatment recently.
  • Patients with serious heart problems.
  • Patients with uncontrolled infections.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an allergy to the study drugs.
  • Patients with a history of severe allergic reactions.
  • Patients who have received an organ transplant.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients who are taking medications that affect the immune system.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

  • Bintrafusp alfa

    is an experimental medication being studied for its potential to help the immune system fight cancer. It works by targeting specific proteins in the body that can suppress the immune response. By blocking these proteins, Bintrafusp alfa aims to enhance the body's natural ability to detect and destroy cancer cells. In this trial, it is being tested to see if it can improve the effectiveness of cancer treatment in patients with advanced sarcoma.

  • Doxorubicin hydrochloride

    is a well-known chemotherapy drug used to treat various types of cancer, including sarcoma. It works by interfering with the DNA inside cancer cells, preventing them from growing and dividing. This helps to slow down or stop the spread of cancer in the body. In this trial, doxorubicin hydrochloride is being used in combination with Bintrafusp alfa to see if the two together can provide better results for patients with advanced sarcoma.

What is already known about the treatment

  • Bintrafusp alfa

    Bintrafusp alfa is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its potential use in treating advanced soft-tissue sarcomas, a type of cancer. The medication works by modulating the immune system to help the body fight cancer cells more effectively. It belongs to a class of drugs known as immune checkpoint inhibitors, which help to enhance the body's natural defenses against tumors.

  • Doxorubicin hydrochloride

    Doxorubicin hydrochloride is administered intravenously, allowing it to enter the bloodstream directly. It is a well-established chemotherapy drug used to treat various types of cancer, including advanced soft-tissue sarcomas. The drug works by interfering with the DNA inside cancer cells, preventing them from growing and dividing. Doxorubicin is classified as an anthracycline antibiotic, a type of chemotherapy that is effective in killing cancer cells.

Investigated diseases

Soft Tissue Sarcoma – Soft tissue sarcoma is a type of cancer that begins in the tissues that connect, support, and surround other body structures. These tissues include muscle, fat, blood vessels, nerves, tendons, and the lining of joints. The disease can develop in any part of the body but is most commonly found in the arms, legs, and trunk. As the disease progresses, it may grow and spread to nearby tissues and organs. In advanced stages, it can metastasize to other parts of the body, such as the lungs. The progression of the disease can vary significantly depending on the specific type and location of the sarcoma.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509497-30-00Protocol codeIB 2020-05Estimated enrolment80 patientsSponsorInstitut Bergonie

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