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Ewing’s sarcoma – Trials in Disease

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Ongoing Clinical Trials for Ewing’s Sarcoma

There are currently 16 clinical trials underway for Ewing’s sarcoma, testing various treatment approaches including new immunotherapies, targeted drugs, and chemotherapy combinations. These trials are being conducted across multiple countries in Europe, offering opportunities for patients with newly diagnosed, relapsed, or treatment-resistant disease to access experimental therapies that may improve outcomes.

Clinical trial locations

Long-term safety study of GD2IL18CART treatment in patients with neuroblastoma, osteosarcoma, Ewing sarcoma, or advanced breast cancer

This trial is designed for patients who have previously received GD2IL18CART therapy in a primary study. The main goal is to monitor the long-term safety of this treatment approach in patients with various cancers including Ewing sarcoma.

Inclusion criteria: To participate, you must have previously received GD2IL18CART treatment in the main clinical trial. You need to be between 2 and 64 years old and have been diagnosed with either neuroblastoma, osteosarcoma, Ewing sarcoma, or advanced breast cancer. You must be willing to participate in long-term safety monitoring and be able to provide informed consent yourself or through a caregiver.

Exclusion criteria: You cannot participate if you are currently pregnant or breastfeeding, have active autoimmune diseases, uncontrolled infections, severe heart, liver, or kidney problems, or active brain metastases that are not controlled. You also cannot join if you have received other experimental treatments within the last 30 days, have inadequate bone marrow function, have known allergies to study treatment components, are participating in other trials, have psychiatric conditions interfering with study compliance, have immunodeficiency disorders, or had major surgery within the last 4 weeks.

Trial focus: The study tracks long-term safety outcomes following GD2IL18CART treatment. Researchers will monitor for any delayed side effects, including infections, disease progression, or new health problems. For younger patients, growth and development will be assessed. Regular blood tests will check for the presence of treatment cells in the body, and the study will track how long treatment responses last.

Investigational treatment: GD2IL18CART is a type of cell therapy where your own immune cells (T cells) are modified in a laboratory to better recognize and fight cancer cells. These modified cells target a protein called GD2 found on cancer cells and contain a component called IL18 that boosts the immune response. This follow-up study monitors the long-term effects of this therapy rather than administering new treatment.

Study of drug combination therapy for patients with recurrent and primary refractory Ewing Sarcoma

This study tests several chemotherapy medications in different combinations to determine which works best for patients whose disease has come back after treatment or did not respond to initial treatment.

Inclusion criteria: You must have a confirmed diagnosis of Ewing sarcoma or similar cancer with evidence of disease progression during or after at least one treatment. You need to be at least 2 years old and medically fit to receive trial treatment. Your kidneys must function adequately with a GFR of 60 ml/min/1.73m² or higher. You must agree to use effective birth control during treatment and for 12 months after, and if you can become pregnant, you need a negative pregnancy test. Imaging tests must be completed within 4 weeks before starting the trial, and you must be eligible for at least two treatment options in the study.

Exclusion criteria: You cannot participate if you have not been diagnosed with Ewing sarcoma, are younger than 6 or older than 65, have not experienced cancer recurrence or resistance to initial treatment, cannot undergo systemic therapy, are unable to complete required imaging tests, cannot provide informed consent, have severe medical conditions making participation unsafe, are currently in other interfering trials, are pregnant or breastfeeding, have allergies to study medications, or cannot comply with study requirements.

Trial focus: The study compares different chemotherapy regimens to find the most effective treatment with the fewest side effects. Treatment involves various combinations of medications given through intravenous infusion or oral capsules. Cycles typically last several weeks, and total treatment may continue for up to 104 weeks depending on response. Throughout the study, doctors monitor tumor size using imaging scans, track side effects, hospital stay duration, time without disease progression, overall survival, and quality of life.

Investigational treatments: The trial tests multiple chemotherapy medications including gemcitabine, docetaxel, irinotecan, temozolomide, topotecan, carboplatin, cyclophosphamide, ifosfamide, etoposide, and lenvatinib in various combinations.

Study of Pembrolizumab and Cabozantinib for Patients with Advanced Sarcomas: Undifferentiated Pleomorphic Sarcoma, Osteosarcoma, and Ewing Sarcoma

This trial tests a combination of two medications—pembrolizumab and cabozantinib—in patients with advanced sarcomas including Ewing sarcoma. The study aims to see if this combination can help control the disease better than standard treatments.

Inclusion criteria: You must have a confirmed diagnosis of undifferentiated pleomorphic sarcoma, osteosarcoma, or Ewing sarcoma with a life expectancy over 3 months. Your disease must be advanced and not eligible for other treatments known to provide significant benefit. You should have no symptoms in your central nervous system and must not be using glucocorticoids regularly. Adequate blood, kidney, liver, and metabolic function are required, with no other cancer diagnosed or treated in the last 2 years except certain skin or cervical cancers. At least three weeks must have passed since last chemotherapy or immunotherapy, and two weeks for other treatments. You must have recovered from previous treatment side effects, be 18 or older, have measurable disease with at least one tumor 10 mm or larger, and have an ECOG performance score of 0-1. Women who can have children need a negative pregnancy test and must use two forms of birth control during the study and for 6 months after.

Exclusion criteria: You cannot participate if you have other cancer types not being studied, had recent cancer treatment within specific timeframes, have serious heart problems, uncontrolled high blood pressure, active infections requiring treatment, are pregnant or breastfeeding, have a history of severe allergic reactions to similar medications, have HIV or other immune system conditions, had an organ transplant, or are taking immune-affecting medications.

Trial focus: The study determines if adding pembrolizumab to cabozantinib can help control advanced sarcomas over a six-month period. Pembrolizumab is given through intravenous infusion while cabozantinib is taken as a tablet. Throughout the 24-month study, doctors use imaging techniques like MRI or CT scans to monitor tumor response and side effects.

Investigational treatments: Pembrolizumab is an immunotherapy that helps your immune system fight cancer by blocking a protein called PD-1 on cancer cells. Cabozantinib targets certain proteins involved in cancer growth and spread, potentially slowing or stopping tumor progression.

Study of Personalized Peptide Vaccine with PERVI-FUS, PERVI-NEO, and 11902A for Children and Young Adults with Metastatic Fusion-Driven Sarcomas

This trial tests an individualized peptide vaccine designed specifically for each patient to help the immune system recognize and attack cancer cells in patients with metastatic fusion-driven sarcomas including Ewing sarcoma.

Inclusion criteria: You must have fusion-driven metastatic sarcoma including Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma and be in your first or second complete remission or partial response. You must have completed local therapy and intensive standard chemotherapy with specific genetic information about your cancer available (whole exome sequencing and RNA sequencing data). A personalized vaccine must have been successfully created for you, and you must have reached complete or stable partial remission after finishing additional cancer treatments.

Exclusion criteria: You cannot participate if you do not have fusion-driven metastatic sarcoma (including specific types like Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma), are not in your first or second complete remission or partial response, are not within the specified age range for children and young adults, or are considered part of a vulnerable population requiring special protection or care.

Trial focus: The study evaluates whether a personalized vaccine can help prevent cancer from returning after standard treatment. The vaccine is made up of small proteins called peptides unique to each patient’s cancer cells. The goal is to boost the immune system’s ability to recognize and attack cancer cells, particularly through T-cell response.

Investigational treatment: The individualized peptide vaccine is a special treatment designed specifically for each patient, made up of small proteins called peptides unique to the cancer cells. It is given as an injection to help the immune system recognize and attack cancer cells more effectively.

Study of Regorafenib with Chemotherapy for Newly Diagnosed Patients with Metastatic Ewing Sarcoma

This trial tests whether adding regorafenib to standard chemotherapy improves treatment outcomes for newly diagnosed patients whose cancer has spread to areas other than the lungs or pleura.

Inclusion criteria: You must have newly diagnosed metastatic Ewing sarcoma that has spread beyond the lungs or pleura, confirmed through specific tests. You need to be between 2 and less than 50 years old and able to swallow and retain oral medication. You must be medically fit to receive standard treatment with adequate blood cell counts, liver and kidney function, heart function (ejection fraction at least 50%), and controlled blood pressure. You cannot have received any prior treatment for Ewing sarcoma except surgery. Female patients who can have children need a negative pregnancy test within 7 days before joining and must agree to use effective birth control during the study and for 12 months after treatment for females or 6 months for males.

Exclusion criteria: You cannot participate if you have Ewing sarcoma that has spread only to the lungs or pleura.

Trial focus: The study aims to find the best dose of regorafenib when used with chemotherapy. Participants receive regorafenib (taken orally as granules or tablets) combined with standard chemotherapy. The study monitors how the body responds to treatment and any side effects, tracking tumor response including whether it shrinks or stops growing over several years.

Investigational treatments: Regorafenib is a medication taken by mouth that blocks certain proteins involved in cancer growth and blood vessel formation. VDC/IE represents a combination of standard chemotherapy drugs (vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide) used together to kill cancer cells.

Study on Dinutuximab Beta and Drug Combination for Children, Teens, and Adults with GD2-Positive Ewing Sarcoma

This trial tests a combination of medications including dinutuximab beta with standard chemotherapy drugs to find the best dose for treating GD2-positive Ewing sarcoma in children, adolescents, and adults.

Inclusion criteria: You must have confirmed Ewing sarcoma or similar cancer with specific genetic changes, have a tumor sample available for testing, and be at least 12 months old. You need to have started first-line standard treatment with at least 14 days since last chemotherapy. Your performance score must indicate adequate ability to carry out daily activities (Lansky score 70% or higher for those under 16, ECOG score 2 or less for 16 and older). You need adequate bone marrow function (white blood cell count over 2000, ANC at least 1000, platelets 75,000 or more, hemoglobin at least 9 g/dL), kidney function (creatinine clearance or GFR greater than 60), liver function (bilirubin, AST, and ALT within acceptable limits), and heart function (left ventricular ejection fraction 50% or more). You cannot have active infections like HIV, HBV, or HCV or severe neurological problems except those caused by the tumor. Females who can have children need a negative pregnancy test and must agree to use birth control during the study and for 3 months after. You must be classified as high risk with disease spread to other body parts and have a tumor testing positive for GD2.

Exclusion criteria: You cannot participate if you have a different cancer type, are not within the specified age range, cannot follow trial procedures or take medications as required, have other serious interfering health conditions, are pregnant or breastfeeding, participated in another recent trial, have allergies to trial medications, or cannot provide informed consent.

Trial focus: The study determines the recommended dose of dinutuximab beta when used with chemotherapy medications including vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. Treatment is given through intravenous infusion in cycles, with regular monitoring for safety, effectiveness, and side effects. The study tracks progression-free survival, event-free survival, and duration of response.

Investigational treatments: Dinutuximab beta is an antibody that targets cancer cells by recognizing the GD2 protein, helping the immune system destroy them. The study also uses standard chemotherapy drugs: vincristine (stops cancer cell growth), doxorubicin (interferes with cancer cell DNA), cyclophosphamide (kills or slows cancer cell growth), ifosfamide (damages cancer cell DNA), and etoposide (prevents cancer cells from dividing).

Study on the Effectiveness and Safety of Naxitamab for Patients with Refractory Ewing’s Sarcoma

This trial evaluates whether adding naxitamab to standard chemotherapy can improve outcomes for patients with refractory Ewing’s sarcoma—disease that has not responded to previous treatments.

Inclusion criteria: You must have confirmed Ewing’s sarcoma in bone or soft tissues with documented evidence that the disease has gotten worse during or after at least one treatment, or has returned after treatment. Your tumor must test positive for the GD2 marker. You need to be between 2 and 21 years old with a life expectancy of at least 12 weeks. Previous cancer treatments must have been completed at least 3 weeks before, major surgery at least 2 weeks before, and radiation therapy at least 4 weeks before joining. You should have recovered from any side effects of previous treatments. If you are at puberty or sexually mature, you must agree to use effective birth control during the study and for at least one year after stopping treatment. A tumor sample must be available for testing, preserved in a specific way.

Exclusion criteria: You cannot participate if you have a different cancer type, are not able to safely receive study treatment due to other health conditions, are pregnant or breastfeeding, cannot follow study procedures or attend required visits, participated in another recent interfering trial, have allergies to study drugs, have certain infections or interfering diseases, or are taking medications that might interfere with study treatment.

Trial focus: The study tests whether adding naxitamab to standard chemotherapy improves treatment outcomes. Naxitamab is given through intravenous infusion along with an arginine-lysine solution to protect the kidneys. Throughout the study, regular monitoring assesses treatment response, safety, side effects, and the treatment’s effects on the body. The trial tracks event-free survival, progression-free survival, overall response rate, and overall survival.

Investigational treatment: Naxitamab is a humanized IgG1 monoclonal antibody that targets the GD2 protein on cancer cells, helping the immune system recognize and destroy them. It is given as a solution for infusion directly into the bloodstream.

Study on the Safety and Dosage of GD2IL18CART for Patients with Relapsed or Refractory GD2 Positive Solid Cancers

This trial tests GD2IL18CART therapy for patients whose cancers have returned or are not responding to standard treatments, including Ewing sarcoma among other cancers.

Inclusion criteria: You must have a diagnosis of relapsed or refractory neuroblastoma, Ewing sarcoma, osteosarcoma, or advanced breast cancer that cannot be cured with standard treatments. For advanced breast cancer, specific prior treatment requirements apply based on hormone receptor status. GD2 expression must be present on tumor cells. You need measurable disease using specific medical scans or tests, be between 1 and 79 years old, and have a certain number of CD3+ T cells in your blood. Those over 16 need an ECOG performance score of 0-2, while those 16 or younger need a Lansky performance score of 60 or higher. Women who can have children need a negative pregnancy test at the start and before chemotherapy.

Exclusion criteria: You cannot participate if you have a history of severe allergic reactions to similar treatments, are currently pregnant or breastfeeding, have uncontrolled infections, have other serious interfering health conditions, received another experimental treatment within the last 30 days, have certain heart problems, have active autoimmune diseases, are unable to follow study procedures, have a history of substance abuse that could affect participation, or had major surgery within the last 4 weeks.

Trial focus: The study determines the safety and appropriate dosage of GD2IL18CART while measuring how well it works in treating these cancers. The therapy involves modifying your own T cells outside the body to better recognize and attack cancer cells. Treatment is given through intravenous infusion with regular monitoring for side effects and response. The study tracks response rates at week 12, including complete or partial remissions, and follows patients for a year to monitor persistence of effects and overall survival.

Investigational treatment: GD2IL18CART is a type of cell therapy using your own immune cells modified to better recognize and attack cancer cells expressing the GD2 marker. The modification uses a gene called GD2CAR-IL18 to help T cells target and destroy cancer cells more effectively.

Study of Regorafenib and Maintenance Chemotherapy for Newly Diagnosed Ewing Sarcoma Patients with Metastatic Disease

This comprehensive trial examines whether adding regorafenib to standard chemotherapy improves results for patients with metastatic disease, investigates whether maintenance therapy prevents cancer from returning, and studies different radiation therapy approaches.

Inclusion criteria: You must have confirmed Ewing sarcoma of bone or soft tissue or similar round cell sarcomas, be at least 2 years old, and provide written informed consent. You need to be medically fit to receive treatment and have received specific chemotherapy treatments (VDC/IE/VC/VAI/BuMel based regimen) with adequate response and no disease progression. You need adequate liver function with specific blood test results within certain ranges. Female patients who can become pregnant need a documented negative pregnancy test. Sexually active patients must agree to use contraception during therapy and for 12 months after last treatment for females or 6 months for males. If requiring radiation therapy, you must be medically fit to receive it.

Exclusion criteria: You cannot participate if you have a different bone cancer type, received previous treatment before enrolling, have significant heart conditions making chemotherapy unsafe, have severe kidney or liver problems, are pregnant or breastfeeding, have active infections requiring treatment, had another cancer in the past 5 years (with certain exceptions), cannot undergo required imaging tests, have certain genetic conditions increasing treatment complication risks, are taking medications that would interact badly with study treatments, or have conditions preventing informed consent.

Trial focus: The study includes multiple randomizations testing different aspects: whether adding regorafenib to standard chemotherapy helps patients with metastatic disease; whether standard or increased radiation dose works better for inoperable tumors; what radiation dose is best after surgery; and whether maintenance therapy with vinorelbine and cyclophosphamide prevents cancer from returning. Throughout the study, regular monitoring includes imaging tests and quality of life assessments.

Investigational treatments: Regorafenib is an oral medication blocking multiple enzymes involved in cancer growth and blood vessel formation. Vinorelbine disrupts cell division by preventing microtubule formation. Cyclophosphamide damages cancer cell DNA, preventing reproduction. These are being tested in various combinations with standard chemotherapy.

Study of Trabectedin and Low-Dose Radiation Therapy for Adults and Young Adults with Advanced or Metastatic Soft Tissue and Bone Sarcomas

This trial combines trabectedin medication with low-dose radiation therapy for patients with advanced or metastatic sarcomas including Ewing’s sarcoma.

Inclusion criteria: You must provide written informed consent, have a performance status of 1 or less (able to carry out light activities), and have good respiratory function if you have lung-related tumors. You need healthy bone marrow function with adequate blood cells, normal levels of blood substances like creatinine and liver enzymes, normal heart function (LVEF 50% or more), and must be tested for hepatitis B and C. A central venous catheter is required. You must be between 16 and 75 years old with advanced or metastatic sarcoma (soft tissue sarcoma, bone tumors like osteosarcoma and chondrosarcoma, or small round-cell sarcomas like Ewing’s sarcoma and rhabdomyosarcoma) that cannot be removed by surgery. The cancer must be in a location allowing safe radiation treatment and must be causing significant symptoms. You need to show disease progression in the last 6 months and be eligible for chemotherapy, having had at least one but no more than three previous treatments. You must have measurable disease. Men and women who can have children must use effective birth control during the study and for 6 months after.

Exclusion criteria: You cannot participate if you have not been diagnosed with the specific sarcoma types being studied, do not have measurable disease, are not an adult or young adult, or are part of a vulnerable population needing special protection.

Trial focus: The study determines how well tumors respond to combining trabectedin with low-dose radiation therapy, particularly in areas receiving radiation. Throughout the study, researchers monitor changes in tumor size, track how long treatment remains effective, and assess effects on pain levels and overall well-being while carefully watching for side effects.

Investigational treatments: Trabectedin is given through intravenous infusion at 1.5 mg per square meter of body surface. It works by interfering with cancer cell growth, slowing their spread. Low-dose radiation therapy uses high-energy rays to target and destroy cancer cells (45 Gy for extremities, 30 Gy for non-extremity areas), carefully controlled to minimize damage to healthy tissues.

Summary

The 16 ongoing clinical trials for Ewing’s sarcoma demonstrate a diverse range of therapeutic approaches. Several trials focus on immunotherapy, particularly targeting the GD2 protein found on cancer cells, with studies testing GD2IL18CART cell therapy, dinutuximab beta, and naxitamab. Multiple trials explore adding targeted drugs like regorafenib, lenvatinib, and cabozantinib to standard chemotherapy regimens.

Geographically, France and Germany lead with the most trials, followed by Spain and Italy, though studies are distributed across 13 European countries. Several multi-national trials span across 5-10 countries, particularly those testing chemotherapy combinations and targeted therapies.

The trials address different patient populations: some focus exclusively on newly diagnosed metastatic disease, others on relapsed or refractory cases, and several include both pediatric and adult patients. Treatment approaches include personalized vaccines, novel immunotherapies, chemotherapy combinations with or without maintenance therapy, radiation therapy dose optimization, and long-term safety follow-up studies.

Notable is the emphasis on combination therapies rather than single agents, with most trials testing whether adding experimental drugs to standard chemotherapy improves outcomes. Several studies also investigate quality of life and long-term effects, recognizing the importance of not just survival but overall patient wellbeing.

Ongoing Clinical Trials on Ewing’s sarcoma

  • Long-term safety study of GD2IL18CART treatment in patients with neuroblastoma, osteosarcoma, Ewing sarcoma, or advanced breast cancer

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of Regorafenib and Maintenance Chemotherapy for Newly Diagnosed Ewing Sarcoma Patients with Metastatic Disease

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France The Netherlands Norway Spain

  • Study on Dinutuximab Beta and Drug Combination for Children, Teens, and Adults with GD2-Positive Ewing Sarcoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia Germany Sweden

  • Study to Find the Right Dose and Safety of Lutetium (177Lu) Edotreotide and Arginine-Lysine in Children with Somatostatin Receptor-Positive Tumors

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study of drug combination therapy for patients with recurrent and primary refractory Ewing Sarcoma

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +4

  • Study on the Effectiveness and Safety of Naxitamab for Patients with Refractory Ewing’s Sarcoma

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on the Safety and Dosage of GD2IL18CART for Patients with Relapsed or Refractory GD2 Positive Solid Cancers

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of Trabectedin and Low-Dose Radiation Therapy for Adults and Young Adults with Advanced or Metastatic Soft Tissue and Bone Sarcomas

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Ewing Sarcoma Treatment with Vinorelbine and Drug Combination for Patients with Primary and Disseminated Disease

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Finland Germany Greece Hungary +2

  • Study of Regorafenib with Chemotherapy for Newly Diagnosed Patients with Metastatic Ewing Sarcoma

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy The Netherlands Spain

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