Ongoing Clinical Trials for Sarcoma
This article provides information about 10 ongoing clinical trials for sarcoma, a type of cancer that affects bones and soft tissues such as muscles, fat, and blood vessels. These trials are testing new treatments including immunotherapy, targeted therapies, and combinations with radiotherapy, and are being conducted across several European countries including Spain, France, Italy, Denmark, and Sweden.
Clinical trial locations
- Denmark
- France
- Study of Atezolizumab Combined with Radiotherapy in Patients with Operable Soft Tissue Sarcomas
- Study on Advanced Soft-Tissue Sarcoma: Testing Futibatinib and Drug Combination for Patients with Unresectable or Metastatic Conditions
- Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
- Study on the Effectiveness of Atezolizumab with Radiotherapy for Patients with Metastatic Colorectal, Lung, Renal, and Sarcoma Cancers
- Study on the Effectiveness of Nivolumab, Ipilimumab, and Pazopanib in Patients with Advanced Rare Sarcomas
- Study of zanidatamab in adult patients with HER2-positive solid tumors (endometrial, colorectal, head & neck, sarcoma) or HER2-mutant non-small cell lung cancer
- Italy
- Spain
- Study of Activated NK Cells for Treating Sarcomas in Children, Adolescents, and Young Adults
- Study of PM14 Alone and with Radiotherapy for Patients with Advanced Soft Tissue Sarcomas and Other Solid Tumors
- Study on CART45RA-NKG2D Cells for Children, Adolescents, and Young Adults with Advanced Sarcoma
- Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
- Sweden
Study of Activated NK Cells for Treating Sarcomas in Children, Adolescents, and Young Adults
This clinical trial is testing a new treatment using activated natural killer (NK) cells combined with IL-2 for children, adolescents, and young adults with sarcomas that have not responded well to standard treatments. The treatment is being conducted in Spain.
Main inclusion criteria: Patients must be between 0 and 40 years old with a confirmed diagnosis of sarcoma that still shows signs of disease after regular treatment or has not benefited from chemotherapy. Patients need a Lansky/Karnofsky index greater than 60%, which measures the ability to perform everyday activities. They must have mild to moderate organ problems but not severe issues, and heart function (left ventricular ejection fraction) above 39%. Women of childbearing age must have a negative pregnancy test and use effective birth control. A suitable haploidentical donor (parent or sibling) must be available.
Main exclusion criteria: Patients with cancers other than sarcomas, those outside the specified age range, those unwilling to follow study procedures, those with serious interfering health conditions, pregnant or breastfeeding women, those who have received recent treatments that might affect results, those with allergies to study medications, active infections requiring treatment, or certain heart, lung, liver, kidney, blood, or immune system disorders.
Focus and goal: The study evaluates the safety of using activated NK cells after lymphoablative chemotherapy and/or low-dose radiotherapy. The treatment aims to enhance the immune system’s ability to fight cancer cells. Researchers will monitor side effects, infections, blood cell recovery, and disease progression over five years using imaging techniques and sample analysis.
Investigational drugs: Activated NK cells are infused intravenously to target and destroy cancer cells. IL-2 is used alongside to boost immune system function and enhance NK cell activity. Lymphoablative chemotherapy reduces immune cells to create space for infused NK cells. Low-dose radiotherapy weakens cancer cells to make them more vulnerable to NK cell attack.
Study of Atezolizumab Combined with Radiotherapy in Patients with Operable Soft Tissue Sarcomas
This trial in France examines the effectiveness of combining atezolizumab (Tecentriq), an immunotherapy medication, with radiotherapy compared to radiotherapy alone in patients with operable soft tissue sarcomas.
Main inclusion criteria: Patients must be 18 years or older with confirmed soft tissue sarcoma suitable for radiotherapy before surgery and surgical removal with curative intent. They must have at least one tumor measuring 10 mm or larger that can be safely biopsied, an ECOG performance status of 0 or 1, adequate blood test results showing sufficient blood cells and normal organ function, and no recent treatments within specified timeframes. Women of childbearing potential must have negative pregnancy tests and use effective birth control.
Main exclusion criteria: Patients under 18 or over 65 years old, pregnant or breastfeeding women, those with previous radiotherapy in the treatment area, metastatic disease, active autoimmune disease requiring systemic treatment, uncontrolled organ disease, HIV or hepatitis infections, recent cancer history, inability to undergo MRI, conditions interfering with study participation, recent trial participation, allergies to study medications, or use of immunosuppressive medications.
Focus and goal: The study evaluates how well the combination treatment works by examining tumor tissue removed during surgery. The main measure is achieving at least 80% tumor death in removed tissue. Researchers will monitor immune system responses and side effects throughout the study.
Investigational drugs: Atezolizumab is given through intravenous infusion to help the immune system recognize and fight cancer cells. Radiotherapy uses high-energy radiation beams to target and destroy cancer cells in specific body areas.
Study of PM14 Alone and with Radiotherapy for Patients with Advanced Soft Tissue Sarcomas and Other Solid Tumors
This Spanish trial tests PM14, a new medication, both alone and combined with radiotherapy for patients with advanced soft tissue sarcomas and other solid tumors.
Main inclusion criteria: Patients must voluntarily sign informed consent, have advanced soft tissue sarcoma or other eligible tumors confirmed by centralized diagnosis with available tumor samples, have received previous chemotherapy for advanced disease, have disease distribution allowing normal tissue radiation constraints, have radiological disease progression within 6 months before study entry, be eligible for systemic chemotherapy with maximum three previous treatments for advanced/metastatic disease, have normal heart function (LVEF at least 50%), be between 18 and 75 years old, have measurable disease, and have performance status of 0 or 1.
Main exclusion criteria: Patients unable to understand or follow study instructions, those with interfering medical conditions, current participation in another trial, past cancer unless treated and cured, pregnancy or breastfeeding, uncontrolled infections, severe allergic reactions history, serious heart, liver, or kidney disease, interfering mental health conditions, use of certain affecting medications, drug or alcohol abuse history, recent major surgery, immune system affecting conditions, or blood clotting disorders.
Focus and goal: The study tests different PM14 dosing schedules alone and with radiotherapy to find the most effective and tolerable administration method. The goal is determining the maximum tolerable dose and evaluating effectiveness in reducing tumor size.
Investigational drugs: PM14 is an investigational anti-cancer agent given intravenously, either as 24-hour or 3-hour infusions. Radiotherapy is combined with PM14 in specific doses over set days to assess combination effectiveness and symptom relief.
Study on Advanced Soft-Tissue Sarcoma: Testing Futibatinib and Drug Combination for Patients with Unresectable or Metastatic Conditions
This French trial uses next generation sequencing (NGS) to analyze genetic material of advanced soft-tissue sarcomas, guiding treatment selection with various medications including Futibatinib and multiple targeted therapies.
Main inclusion criteria: Patients must be at least 18 years old, eligible for first-round systemic treatment, have no other cancer diagnosed or treated in the last two years except certain non-affecting types, have social security as required by French law, voluntarily sign written consent, have confirmed unresectable or metastatic soft-tissue sarcoma, have no previous systemic treatment for advanced cancer, have ECOG performance status 0 or 1, have adequate blood and body functions, have measurable disease, and have suitable frozen tumor material or accessible tumor for biopsy.
Main exclusion criteria: Patients with unresectable locally advanced and/or metastatic soft-tissue sarcoma that has spread and cannot be surgically removed.
Focus and goal: The study determines the feasibility of using NGS to provide detailed genetic reports helping doctors make informed treatment decisions. It monitors progression-free survival, overall survival, treatment response, quality of life, and evaluates cost-effectiveness of using NGS in treatment planning.
Investigational drugs: NGS technology analyzes tumor genetic material to identify specific genetic changes driving cancer, helping make informed treatment decisions for each patient.
Study on CART45RA-NKG2D Cells for Children, Adolescents, and Young Adults with Advanced Sarcoma
This Spanish trial tests CART45RA-NKG2D cells, a form of cell therapy using modified immune cells to help fight advanced sarcomas in children, adolescents, and young adults.
Main inclusion criteria: Patients must be 40 years or younger at sarcoma recurrence or progression, with cancer that has returned or not responded to standard treatments and is considered incurable. Patient or legal representative must provide written consent. Sexually active patients must use effective birth control for 6 months after treatment. Sarcoma samples must show positive NKG2DL expression (at least 50% of tumor cells). Patients must have measurable or evaluable tumors, life expectancy of at least 10 weeks, Lansky score of 50 or greater (under 16) or Karnofsky score of 50 or greater (16 and older), have recovered from previous treatment effects, have adequate bone marrow function, and have normal liver and kidney function.
Main exclusion criteria: Patients with cancers other than sarcoma, those outside the specified age range, those unable to safely receive treatment due to other health conditions or risks, pregnant or breastfeeding patients, those who received recent interfering treatments, those with active infections or serious illnesses, and those unable to follow study procedures or attend follow-up visits.
Focus and goal: The study determines safety and feasibility of this new treatment by giving increasing cell doses and monitoring responses. It assesses treatment effectiveness in reducing tumor size and monitors side effects and treatment persistence in the body.
Investigational drugs: NKG2D-CAR Memory T Cells are modified immune cells with added chimeric antigen receptors targeting NKG2D protein on cancer cell surfaces, enhancing the immune system’s ability to attack tumors.
Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
This trial across Denmark, Italy, France, and Spain tests BAY 2927088, an oral medication, for patients with advanced solid tumors having HER2 mutations.
Main inclusion criteria: Patients must have advanced solid tumors that cannot be surgically removed (including colorectal, biliary tract, bladder, cervical, endometrial, and other solid tumors except lung cancer), be at least 18 years old, have tried standard treatments or have no satisfactory alternatives, have activating HER2 mutation, and have at least one measurable cancer area trackable by RECIST 1.1 criteria.
Main exclusion criteria: Patients with cancers other than advanced solid tumors, those without HER2 mutation, those outside specified age range, those unwilling to follow study procedures, pregnant or breastfeeding patients, those with interfering medical conditions, recent trial participants, or those with allergies to study medication.
Focus and goal: The study evaluates BAY 2927088 effectiveness and safety in treating advanced solid tumors with HER2 mutations, monitoring tumor response, side effects, quality of life, and long-term treatment effects.
Investigational drugs: BAY 2927088 is an oral reversible tyrosine kinase inhibitor targeting specific proteins involved in cancer cell growth and spread, being tested for reducing tumor size or stopping growth in HER2-mutated tumors.
Study on the Effectiveness of Atezolizumab with Radiotherapy for Patients with Metastatic Colorectal, Lung, Renal, and Sarcoma Cancers
This French trial evaluates the combination of atezolizumab with stereotactic ablative radiotherapy (SABR) for patients with metastatic tumors including sarcomas.
Main inclusion criteria: Patients must be 18 years or older without major unsafe health conditions, have accessible tumors for biopsy with additional written consent, have social security, have confirmed metastatic solid tumors (including sarcomas) treated according to standard recommendations, have at least one tumor measurable and treatable with SABR (4 cm or smaller) plus at least one untreated measurable tumor, have WHO performance status 0-1, be evaluated by radiation oncologist within 45 days before joining including imaging tests, have adequate organ function confirmed by blood tests, have life expectancy over 3 months, understand the experimental nature and provide written consent, and use effective birth control methods during and after the study.
Main exclusion criteria: Patients with metastatic tumors in colorectal, non-small cell lung, renal, and sarcoma types, those outside specified age range, those not in specified trial groups, those not male or female, and those considered part of vulnerable populations.
Focus and goal: The study evaluates treatment effectiveness in preventing cancer progression over one year, monitoring health and disease progression, providing information on potential benefits and risks of combining atezolizumab with SABR.
Investigational drugs: Atezolizumab is an anti-PD-L1 antibody helping the immune system recognize and attack cancer cells. SABR delivers precise high-dose radiation to cancer cells while minimizing damage to surrounding healthy tissue.
Study on the Effectiveness of Nivolumab, Ipilimumab, and Pazopanib in Patients with Advanced Rare Sarcomas
This French trial compares two treatment approaches: nivolumab and ipilimumab combination versus pazopanib alone for metastatic or unresectable advanced rare sarcomas.
Main inclusion criteria: Patients must be at least 18 years old, have biopsy-confirmed rare sarcoma (specific types listed including angiosarcoma, alveolar soft part sarcoma, and others), have metastatic or unresectable cancer not responding to standard treatments or where none exist, have measurable disease according to specific criteria, have been treated with anthracycline chemotherapy unless unsuitable, have ECOG Performance Status 0 or 1, have normal organ and bone marrow function, have negative pregnancy test (women of childbearing potential), agree to use effective birth control during and after study, be able to attend follow-up visits, have medical insurance, and sign informed consent.
Main exclusion criteria: Patients with different cancers than specified rare sarcomas, those with recent cancer treatments within certain timeframes, those with interfering medical conditions, pregnant or breastfeeding patients, those with active infections or serious illnesses, those with previous allergic reactions to study drugs, and those unable to follow study procedures.
Focus and goal: The study evaluates how long patients live without cancer worsening (progression-free survival), overall treatment response, response duration, overall survival, and quality of life. It also conducts research to identify potential response predictors and explore new therapy targets.
Investigational drugs: Nivolumab and ipilimumab are immune checkpoint inhibitors helping the immune system recognize and attack cancer cells more effectively. Pazopanib targets certain proteins in cancer cells to help stop cancer growth and spread.
Study of zanidatamab in adult patients with HER2-positive solid tumors (endometrial, colorectal, head & neck, sarcoma) or HER2-mutant non-small cell lung cancer
This French trial tests zanidatamab (JZP598) for patients with various solid tumors including sarcomas showing high HER2 protein levels or HER2 gene mutations.
Main inclusion criteria: Patients must be at least 18 years old, have confirmed diagnosis of specific cancers (including sarcoma), have advanced, spread, or surgically unremovable cancer, have received at least one previous treatment no longer working, have adequate liver function, good heart function with heart pumping capacity at least 50%, adequate kidney and bone marrow function, measurable disease evaluable by scans, life expectancy over 3 months, performance status 2 or better, provide suitable tumor tissue sample or agree to biopsy, agree to use effective birth control, have negative pregnancy test (women of childbearing potential), be willing to follow all study procedures, and sign informed consent.
Main exclusion criteria: Prior HER2-directed therapy within 4 weeks, active untreated or unstable brain metastases, other cancer history within past 2 years except successfully treated specific types, severe heart conditions, active or uncontrolled infections requiring treatment, HIV or active hepatitis infections, serious interfering medical conditions, pregnant or breastfeeding women, inability to swallow oral medications, known allergies to study medication components, and recent trial participation within 4 weeks.
Focus and goal: The study evaluates zanidatamab effectiveness in treating various HER2-positive solid tumors by monitoring tumor response through regular scans and checking for side effects.
Investigational drugs: Zanidatamab is an antibody-based therapy targeting HER2 protein on cancer cells by attaching to two different sites simultaneously, helping stop or slow cancer growth.
Study on Triptorelin for Fertility Protection in Young Women and Teenagers Undergoing Chemotherapy for Breast Cancer, Leukemia, Lymphomas, and Sarcomas
This Swedish trial investigates whether GnRHa (Pamorelin) can help protect fertility in young women and teenagers undergoing chemotherapy for various cancers including sarcomas.
Main inclusion criteria: Patients need signed informed consent, must be 14-42 years old at cancer diagnosis, be women with specific cancers (including sarcomas) confirmed by histology and assigned for disease-specific chemotherapy, have confirmed menarche (started menstrual periods), have Lansky score 50 or greater (under 16) or Karnofsky score 50 or greater (16 and older), have recovered from previous cancer treatment effects, have adequate bone marrow function with certain blood cell levels without regular transfusions, and have normal liver and kidney function.
Main exclusion criteria: Non-female patients, patients without specified cancers (including sarcomas), those outside specified age range, those not able to safely receive treatment due to other health conditions, pregnant or breastfeeding patients, those with recent interfering treatments, those with active infections or serious illnesses, and those unable to follow study procedures.
Focus and goal: The study explores whether GnRHa can help protect fertility by examining ovarian reserve changes after chemotherapy, following participants for several years with regular check-ups including ultrasounds and blood tests measuring hormone levels.
Investigational drugs: GnRHa temporarily puts ovaries to rest, potentially shielding them from harmful chemotherapy effects to help preserve future fertility by maintaining ovarian health during cancer treatment.
Summary
These 10 clinical trials represent diverse approaches to treating sarcomas across different patient populations. Several trials focus specifically on children, adolescents, and young adults, including studies in Spain testing activated NK cells and CART45RA-NKG2D cells for advanced disease. France hosts multiple trials, including studies combining immunotherapy with radiotherapy and trials using genetic profiling to guide treatment selection. Spain is also testing PM14, a new medication, both alone and with radiotherapy.
A notable feature is the emphasis on immunotherapy approaches, with multiple trials testing immune checkpoint inhibitors like atezolizumab, nivolumab, and ipilimumab, either alone or combined with radiotherapy. Several studies focus on patients with specific genetic characteristics, particularly HER2 mutations or overexpression, testing targeted therapies like BAY 2927088 and zanidatamab across multiple European countries including Denmark, Italy, France, and Spain.
The trials address various stages of disease, from operable tumors to advanced metastatic conditions. Some studies specifically target rare sarcoma subtypes, while others include sarcomas as part of broader solid tumor investigations. One unique trial in Sweden focuses on fertility preservation in young patients undergoing chemotherapy, recognizing the long-term quality of life concerns for younger patients.
These trials reflect the evolving landscape of sarcoma treatment, moving towards personalized medicine approaches based on genetic characteristics, immunotherapy combinations, and treatments tailored to specific patient populations and disease stages.
