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Study on Sunitinib and Nivolumab with Chemotherapy for Patients with Advanced Soft Tissue and Bone Sarcomas

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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 treatments for advanced forms of soft tissue and bone sarcomas, which are types of cancer that develop in the body's connective tissues, such as muscles, fat, and bones. The study is testing the effectiveness of two medications, Sutent (also known as sunitinib) and Opdivo (also known as nivolumab), both of which are used to treat certain types of cancer. Sutent is taken as a capsule, while Opdivo is given through an infusion into a vein. The trial also involves chemotherapy, which is a common cancer treatment that uses drugs to kill cancer cells.

The purpose of this study is to find the best dose of the combination of Sutent and Opdivo and to see how well this combination works in stopping the cancer from getting worse. The study is divided into different stages and groups, with some groups receiving different combinations of treatments. For example, one group will receive Sutent and Opdivo together, while another group will receive Opdivo with other chemotherapy drugs like epirubicin and ifosfamide. The study will also look at how safe these treatments are and how they affect the patients' overall health.

Participants in the study will receive their assigned treatments and will be monitored over time to see how their cancer responds. The study aims to determine how long patients can live without their cancer getting worse and to assess the overall survival rate. The trial will also collect information on any side effects experienced by participants to ensure the treatments are as safe as possible. The study is expected to continue until 2025, with the goal of improving treatment options for people with advanced soft tissue and bone sarcomas.

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 treatment phase

    The trial begins with the administration of sunitinib and nivolumab. Sunitinib is provided in the form of hard capsules, taken orally. The dosage is 12.5 mg or 25 mg, depending on the specific requirements of the trial phase.

    The nivolumab is administered as a solution for infusion, which means it is given through a vein. The concentration is 10 mg/mL. The frequency and duration of administration are determined by the trial protocol.

  2. Step 2

    Dose determination

    In the initial phase, the main objective is to determine the recommended dose of the sunitinib and nivolumab combination for the next phase of the trial. This involves monitoring for any adverse effects and adjusting doses as necessary.

  3. Step 3

    Efficacy evaluation

    The trial then evaluates the effectiveness of the sunitinib and nivolumab combination. This is measured by the progression-free survival rate at 6 months for most patients, and at 12 months for specific cohorts.

    Progression-free survival rate refers to the percentage of patients who do not experience disease progression or death within the specified timeframe.

  4. Step 4

    Cohort-specific treatment

    For certain cohorts, additional combinations of medications are tested. For example, in cohort 7, the combination of epirubicin, ifosfamide, and nivolumab is used to determine the maximum tolerated dose.

    In cohort 8, the combination of MAP (a chemotherapy regimen) and nivolumab is tested similarly.

  5. Step 5

    Safety and response assessment

    Throughout the trial, the safety profile of the treatments is assessed. This includes monitoring the type, incidence, and severity of any adverse events.

    The overall response rate is also evaluated, which is the number of patients who achieve a complete or partial response to the treatment.

  6. Step 6

    Follow-up and conclusion

    After the treatment phases, patients are monitored for overall survival and any long-term effects of the treatment.

    The trial is estimated to conclude by May 31, 2025, with ongoing follow-up to assess the long-term outcomes of the treatments.

Who can join the trial?

17 criteria

  • Patients must provide written informed consent before any study-specific procedures and agree to follow the treatment and follow-up plan.
  • Patients must have a confirmed diagnosis of advanced soft tissue or bone sarcomas.
  • Patients must have measurable disease according to RECIST 1.1 criteria, which is a standard way to measure how well a cancer treatment is working.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
  • Patients must have adequate liver, kidney, heart, and blood function.
  • Laboratory tests must show:
    • Absolute neutrophil count (a type of white blood cell) of at least 1,200/mm³.
    • Platelet count (cells that help blood clot) of at least 100,000/mm³.
    • Bilirubin (a substance made by the liver) of 1.5 mg/dL or less.
    • Prothrombin time (PT) and International Normalized Ratio (INR) of 1.5 or less, unless on blood thinners.
    • AST and ALT (liver enzymes) of 2.5 times the upper limit of normal or less.
    • Creatinine (a waste product filtered by the kidneys) of 1.5 mg/dL or less, or creatinine clearance of at least 60 ml/min.
    • Calcium of 12 mg/dL or less.
    • Left ventricular ejection fraction (a measure of heart function) must be 50% or higher, as shown by an echocardiogram or MUGA scan.
    • Females of childbearing potential must have a negative pregnancy test within 24 hours before joining the study and agree to use birth control during the study and for 7 months after it ends. Patients must not be pregnant or nursing when starting the study. Both women and men of reproductive potential must agree to use effective birth control methods.
    • Patients must be between the ages of 12 and 80 years old, depending on the specific cohort they are in.
    • Patients must provide tumor tissue samples for central pathology review and research purposes.
    • Patients must not have received previous treatment with certain drugs, depending on the specific cohort they are in.

Who cannot join the trial?

6 criteria

  • Patients who have not been diagnosed with advanced soft tissue and bone sarcomas cannot participate. Sarcomas are a type of cancer that starts in tissues like muscle, fat, or bone.
  • Patients who are not within the specified age ranges cannot participate. The age ranges are typically defined by the study and may include children, adults, or older adults.
  • Patients who are not part of the specified clinical trial groups cannot participate. These groups are defined by the study and may include specific types of sarcomas or other criteria.
  • Patients who are not able to take the study medications, such as sunitinib, nivolumab, epirubicin, ifosfamide, doxorubicin, dacarbazine, or MAP, cannot participate. These are medications used in cancer treatment.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give informed consent, may not be eligible to participate.
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Investigated drugs

  • Sunitinib

    is a medication used in this trial to help treat advanced soft tissue and bone sarcomas. It works by blocking certain proteins that promote cancer cell growth, which may help slow down or stop the progression of the cancer.

  • Nivolumab

    is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. In this trial, it is used in combination with other treatments to enhance the body's ability to fight the cancer.

  • Epirubicin

    is a chemotherapy drug used in this trial to treat certain types of sarcomas. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

  • Ifosfamide

    is another chemotherapy medication included in the trial. It is used to treat various cancers by damaging the DNA of cancer cells, which can lead to their death.

  • Doxorubicin

    is a chemotherapy drug that is part of the trial's treatment plan for certain sarcomas. It works by disrupting the DNA inside cancer cells, which can help stop their growth.

  • Dacarbazine

    is a chemotherapy medication used in this trial to treat leiomyosarcoma. It works by slowing or stopping the growth of cancer cells.

What is already known about the treatment

  • Sunitinib

    Sunitinib is administered orally in the form of capsules. It is currently being studied in combination with nivolumab for its effectiveness in treating advanced soft tissue and bone sarcomas. The main therapeutic indication for sunitinib is its use in cancer treatment, particularly for certain types of sarcomas. At the molecular level, sunitinib works by inhibiting multiple receptor tyrosine kinases, which are involved in tumor growth and angiogenesis. It is classified as a tyrosine kinase inhibitor.

  • Nivolumab

    Nivolumab is administered intravenously as an infusion. It is being evaluated in combination with sunitinib and chemotherapy for its potential benefits in advanced soft tissue and bone sarcomas. The primary therapeutic indication for nivolumab is in cancer immunotherapy. Its mechanism of action involves blocking the PD-1 receptor on T-cells, enhancing the immune system's ability to attack cancer cells. Nivolumab is classified as an immune checkpoint inhibitor.

  • Epirubicin

    Epirubicin is given intravenously and is part of a combination therapy being tested for undifferentiated pleomorphic sarcoma. It is primarily used in chemotherapy for various cancers. Epirubicin works by intercalating DNA strands, disrupting the replication process, and is classified as an anthracycline antibiotic.

  • Ifosfamide

    Administered intravenously, ifosfamide is being studied in combination with nivolumab for its effects on undifferentiated pleomorphic sarcoma. It is used in chemotherapy to treat different cancers. Ifosfamide acts by cross-linking DNA strands, preventing cell division, and is classified as an alkylating agent.

  • Doxorubicin

    Doxorubicin is administered intravenously and is part of a combination therapy for leiomyosarcoma. It is widely used in chemotherapy for various cancers. Doxorubicin works by intercalating DNA, inhibiting topoisomerase II, and is classified as an anthracycline antibiotic.

  • Dacarbazine

    Dacarbazine is given intravenously and is being tested in combination with nivolumab for leiomyosarcoma. It is used in chemotherapy for treating certain cancers. Dacarbazine acts as an alkylating agent, interfering with DNA replication, and is classified as an antineoplastic agent.

Investigated diseases

Advanced Soft Tissue and Bone Sarcomas – These are a group of cancers that originate in the connective tissues, which include muscles, fat, blood vessels, nerves, tendons, and the lining of the joints. They can occur in any part of the body but are most commonly found in the arms, legs, and trunk. The disease often begins as a painless lump or swelling and may grow over time. As the sarcoma progresses, it can invade nearby tissues and spread to other parts of the body. The progression can vary significantly depending on the specific type of sarcoma and its location. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514776-40-00Protocol codeGEIS-52Estimated enrolment189 patientsSponsorAsoc Grupo Espanol De Investigacion En Sarcomas

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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).