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Soft tissue sarcoma – Trials in Disease

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Ongoing Clinical Trials for Soft Tissue Sarcoma

Currently, there are 23 ongoing clinical trials investigating new treatments and treatment combinations for soft tissue sarcoma across Europe. These studies focus on various stages of the disease, from resectable tumors to advanced or metastatic forms, testing chemotherapy medications, immunotherapies, targeted therapies, and combinations with radiotherapy. Trials are being conducted in multiple countries including France, Germany, Belgium, Spain, Italy, Poland, Denmark, and Norway.

Clinical trial locations

Comparison of Cyclophosphamide and Doxorubicin for Treatment of Advanced or Metastatic Soft Tissue Sarcoma in Patients Age 65 and Older

This trial focuses on elderly patients aged 65 and older with advanced or metastatic soft tissue sarcoma. It compares two different treatment approaches: oral cyclophosphamide versus intravenous doxorubicin.

Main inclusion criteria: Patients must be at least 65 years old, with confirmed soft tissue sarcoma that has spread or advanced and cannot be treated with surgery or curative radiotherapy. The disease must show progression within the last 6 months. Patients need measurable tumors on CT scan, good heart function with ejection fraction of 55% or higher, adequate blood cell counts, and normal kidney and liver function. They must be able to perform daily activities with minimal assistance and have a life expectancy of at least 6 months.

Main exclusion criteria: Patients under 65 years old cannot participate. Those with cancer types other than soft tissue sarcoma, without advanced or metastatic disease, or who have previously received cyclophosphamide or doxorubicin are excluded. Patients with severe heart, kidney, or liver problems, pregnancy or breastfeeding, active infections, or other serious medical conditions that could interfere with participation are not eligible.

Focus of the trial: The study examines whether cyclophosphamide offers better outcomes compared to doxorubicin in elderly patients with this type of cancer. Researchers will monitor overall health, cancer progression, quality of life, and any side effects throughout the treatment period, with special attention to elderly patients’ specific health needs and daily functioning abilities.

Investigational drugs: Cyclophosphamide is an oral chemotherapy medication that interferes with cancer cell DNA replication and division, preventing cancer cells from multiplying effectively. Doxorubicin is an intravenous chemotherapy from the anthracycline class that works by inserting itself into cancer cell DNA and inhibiting an enzyme essential for cell division and growth.

Study of ADCE-D01 for Patients with Metastatic or Unresectable Soft Tissue Sarcoma

This trial evaluates a new medication called ADCE-D01, which is a humanized antibody-drug conjugate designed to target and attack cancer cells. The study is conducted across Germany, Belgium, and France.

Main inclusion criteria: Participants must be at least 18 years old with a life expectancy of at least 3 months. They need confirmed soft tissue sarcoma that has spread or cannot be surgically removed, with previous chemotherapy treatment including anthracyclines (unless unsuitable). The disease must be progressing with at least one measurable tumor. Patients need acceptable blood and organ function levels, including specific hemoglobin, white blood cell, platelet counts, and liver/kidney function tests. Women of childbearing potential need negative pregnancy tests and must use birth control. Men must use condoms during treatment.

Main exclusion criteria: Patients with other cancer types besides soft tissue sarcoma, those who haven’t recovered from previous treatments, or those with severe heart problems are excluded. Uncontrolled infections, pregnancy or breastfeeding, history of severe allergic reactions to similar drugs, and inability to follow study procedures also exclude participation.

Focus of the trial: The study is divided into two phases. Phase 1a focuses on finding the appropriate dose through gradual increase while monitoring safety. Phase 1b confirms the dosage. Phase 2 evaluates the antitumor activity at the confirmed dose. Throughout all phases, researchers closely monitor patient response, side effects, and overall health status.

Investigational drug: ADCE-D01 is a 5T4 antibody-drug conjugate administered intravenously every three weeks. It combines an antibody targeting a specific protein on cancer cells with a drug that helps stop cancer cell growth and division.

Study of BT-001 and Pembrolizumab for Patients with Advanced Solid Tumors, Including Sarcoma, Merkel Cell Carcinoma, Melanoma, Breast, and Lung Cancer

This trial, conducted in France and Belgium, tests BT-001 (administered directly into tumors) both alone and in combination with pembrolizumab (given through intravenous infusion) for various advanced cancers including soft tissue sarcoma.

Main inclusion criteria: Participants must provide signed consent and use effective contraception methods combined with barrier protection. They need complete COVID-19 vaccination at least 30 days before treatment, with an interval of at least 3 weeks from last chemotherapy. Patients must be 18 or older with confirmed diagnosis of advanced or metastatic sarcoma with easily injectable lesions, having tried and not responded to standard treatments. They need at least one injectable lesion, an expected survival of at least 3 months, adequate blood/liver/kidney function, and ECOG performance status of 0 or 1.

Main exclusion criteria: Patients with other cancer types not listed, those below required age, inability to give consent, pregnancy or breastfeeding, severe uncontrolled medical conditions, recent cancer treatments that might interfere, known allergies to study medications, participation in another trial simultaneously, history of certain heart conditions, and active infections requiring treatment are excluded.

Focus of the trial: The study evaluates both safety and effectiveness of BT-001 alone (Phase I Part A) and combined with pembrolizumab (Phase I Part B and Phase II). Researchers monitor response to treatment and side effects through regular check-ups and assessments, focusing on how well this combination stimulates the immune system to fight cancer.

Investigational drugs: BT-001 is injected directly into tumors to stimulate the immune system. Pembrolizumab is given intravenously and helps the immune system attack cancer cells by blocking a protein that prevents immune recognition of cancer.

Study of Cirtuvivint for Patients with Advanced Soft-Tissue Sarcomas as a Second-Line Treatment

This Spanish trial evaluates Cirtuvivint (taken as tablets) as second-line therapy for specific advanced soft tissue sarcoma subtypes including leiomyosarcoma, solitary fibrous tumor, synovial sarcoma, and myxoid liposarcoma.

Main inclusion criteria: Patients must provide written informed consent and be between 16 and 70 years old. They need confirmed diagnosis of specific advanced soft tissue sarcoma subtypes that cannot be surgically removed, with metastatic or locally advanced disease showing recent progression. Previous anthracycline treatment is required (unless unsuitable for solitary fibrous tumor). The disease must be measurable according to RECIST 1.1 criteria. Patients need mandatory tumor samples for analysis, ECOG Performance Status of 0-1, and adequate liver, kidney, heart, and blood function including specific laboratory values.

Main exclusion criteria: Patients with medical conditions other than selected advanced soft tissue sarcomas, those outside specified age ranges, not part of specified clinical trial groups, and not considered part of vulnerable populations cannot participate.

Focus of the trial: The study assesses how well Cirtuvivint works in preventing cancer progression over three months. Researchers monitor patient response, safety, tolerability, and overall health through regular check-ups and tests. The trial provides valuable information on Cirtuvivint’s effectiveness and safety for these specific sarcoma types, with expected conclusion by July 2027.

Investigational drug: Cirtuvivint is administered orally as tablets. It works by inhibiting certain proteins involved in cell growth, which may help slow down or stop cancer progression. It’s classified as a targeted cancer therapy currently under investigation.

Study of cobimetinib and atezolizumab combination therapy in children and adults with advanced or metastatic soft tissue sarcoma

This French trial investigates combining cobimetinib (oral tablets) with atezolizumab (intravenous infusion) for advanced or metastatic soft tissue sarcoma in both children and adults, specifically focusing on rhabdomyosarcoma and Malignant Peripheral Nerve Sheath Tumors.

Main inclusion criteria: Participants must be at least 12 years old with confirmed soft tissue sarcoma diagnosis verified by a pathologist. They need good physical performance (Karnofsky score ≥70% for those 12 and older, ECOG 0-1 for adults), life expectancy of at least 16 weeks, and adequate organ function shown by sufficient blood cell counts, normal kidney function, acceptable liver function, and normal blood clotting. Patients must have recovered from previous treatment side effects (except hair loss and mild nerve problems), have received previous chemotherapy, have at least one measurable tumor, provide written consent, have health insurance coverage, and have suitable tumor tissue available for testing. Disease progression must be documented through imaging tests, and adult patients need tumors that can be safely sampled through biopsy.

Main exclusion criteria: Children younger than 6 months or older than 12 years are excluded. Patients without advanced or metastatic soft tissue sarcoma, without specific tumor types (rhabdomyosarcoma, MPNST, or complex genomics sarcomas), unable to take study medications, or unable to undergo required tests are not eligible. Patients with certain medical conditions that might interfere with treatment also cannot participate.

Focus of the trial: The study is conducted in two parts: first checking if the combination is safe for younger children, then examining effectiveness in different patient groups based on sarcoma type. Researchers monitor response through regular medical evaluations, imaging at 8 and 16 weeks, and track side effects, disease-free time, local recurrence rates, and overall survival until February 2026.

Investigational drugs: Cobimetinib blocks specific proteins (MEK1 and MEK2) that cause cancer cell growth. Atezolizumab helps the immune system fight cancer by blocking the PDL1 protein that cancer cells use to hide from immune detection.

Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas

This Danish study tests a new imaging method combining Magnetic Resonance Spectroscopy using hyperpolarized [1-13C]pyruvate with PET scanning using Fluor-18-FDG for various cancers including sarcomas. The research aims to determine if both imaging methods can be performed simultaneously to better understand tumor energy metabolism.

Main inclusion criteria: Participants must be adults aged 18 or older (both men and women) with confirmed diagnosis of breast cancer, neuroendocrine neoplasm, lymphoma, or sarcoma. The tumor must be at least 1.5 centimeters in size, and patients must not be part of vulnerable population groups.

Main exclusion criteria: Patients under 18 or over 65 years old, unable to lie still in the PET/MR scanner for up to 60 minutes, with claustrophobia, metal implants not compatible with MRI, pregnancy or breastfeeding, severe kidney dysfunction, known allergies to imaging substances, receipt of experimental drugs within 30 days, inability to provide consent, uncontrolled medical conditions, weighing more than 180 kg (scanner limitations), or blood glucose levels above 200 mg/dL at imaging time are excluded.

Focus of the trial: The study examines whether both imaging techniques can work together effectively to visualize how tumors process different nutrients. Participants undergo a single imaging procedure where they receive two injectable substances through an intravenous line, then are scanned using a combined PET/MR scanner to measure tumor activity and metabolism.

Investigational drugs: Hyperpolarized [1-13C]Pyruvate allows real-time visualization of metabolic processes, particularly how tumors break down pyruvate. 18F-FDG is a radioactive glucose form that accumulates in cancer cells, which typically consume more glucose than healthy cells, making them visible on PET scans.

Study of JK06 for Patients with Advanced or Metastatic Cancer

This trial, conducted in Belgium and Spain, studies JK06, a 5T4 antibody-drug conjugate, for patients with unresectable locally advanced or metastatic cancer including soft tissue sarcoma. The study includes two phases: finding the right dose and further evaluating effects at the selected dose.

Main inclusion criteria: Participants must be at least 18 years old, agree to fresh tumor biopsy if required, with women of childbearing potential needing negative pregnancy tests and using two forms of effective birth control. Men with partners who can have children must use effective barrier contraception. Patients need life expectancy of at least 12 weeks, willingness to attend clinic visits and follow procedures. For initial phase, patients need unresectable and spread/advanced specific cancer types having tried standard treatments or unable to receive them. For expansion phase, patients need specific cancer types with certain previous treatments (no more than specified number). Patients need performance status of 0 or 1, measurable disease by imaging tests, and acceptable laboratory results including specific albumin, platelet, hemoglobin, and other blood component levels.

Main exclusion criteria: Recent other cancer treatment, certain health conditions that could interfere, pregnancy or breastfeeding, allergies to study medication or ingredients, inability to follow procedures or attend visits, simultaneous participation in another trial, history of certain heart conditions, uncontrolled infections or serious illnesses, recent or planned surgery during study, and history of substance abuse that could interfere are excluded.

Focus of the trial: The study evaluates safety and tolerability of JK06 when given intravenously every three weeks, while determining the most effective dose. Participants are closely monitored for response and side effects through regular check-ups, with imaging and blood tests to assess treatment effectiveness.

Investigational drug: JK06 is a 5T4 antibody-drug conjugate that combines an antibody specifically targeting the 5T4 protein on cancer cells with a drug that can kill these cells, designed to deliver cytotoxic agents directly to cancer cells while minimizing damage to normal cells.

Study on Aldesleukin and Dendritic Cell Vaccine for Patients with Resected Stage IV Neuroendocrine Tumors and Soft Tissue Sarcoma

This Italian trial studies a special vaccine (DC-VACCINE_IRSTIRCCS) made from patients’ own tumor cells combined with Proleukin (aldesleukin) for neuroendocrine tumors and soft tissue sarcoma. The study evaluates safety and effectiveness in helping the immune system fight cancer.

Main inclusion criteria: Patients must have confirmed stage IV neuroendocrine tumors or soft tissue sarcoma with complete surgical removal of tumor. Both female patients who can have children and all male patients must agree to use highly effective birth control from consent signing until three months after study ends. Patients need willingness to provide written consent, have surgical tissue sample collected and sent to specific lab meeting quality standards, be disease-free on CT/MRI scan within 60 days before joining, need only observation with no standard treatment available after surgery, recovered from surgical side effects to mild level or less, be at least 18 years old, have ECOG performance status 0 or 1, and have acceptable organ function including specific hemoglobin, blood cell counts, liver enzyme levels, bilirubin, and creatinine levels. Patients aged 70 or older need left ventricular ejection fraction of at least 55% by echocardiogram.

Main exclusion criteria: Patients with other cancer types than neuroendocrine tumors or soft tissue sarcoma, outside specified age range, or part of vulnerable populations cannot participate.

Focus of the trial: Participants receive DC-VACCINE_IRSTIRCCS injections intradermally and Proleukin (aldesleukin) subcutaneously at 18 million international units per administration over six months. Researchers monitor safety, immunological efficacy, overall survival, and relapse-free survival through regular follow-up visits including physical examinations and laboratory tests.

Investigational drug: Dendritic Cells Loaded with Autologous Tumor Homogenate use immune cells taken from patients and loaded with their own tumor material to help the immune system recognize and attack remaining cancer cells after surgical removal.

Study on Ifosfamide and Doxorubicin for Patients with High-Grade Soft Tissue Sarcoma in the Limbs and Trunk Wall

This Norwegian trial tests the combination of ifosfamide and doxorubicin given through intravenous infusion for high-grade soft tissue sarcoma in arms, legs, and trunk. Both medications are given as solutions sequenced to evaluate tumor shrinkage before surgery.

Main inclusion criteria: Participants must be 18 years or older with adequate organ function and bone marrow reserve, showing hemoglobin 8.0 g/dL or higher, neutrophil count 1.0 x 109/L or higher, platelet count 75 x 109/L or higher, total bilirubin 1.5 times normal limit or lower, and creatinine clearance 60 ml/min or higher. Patients need negative tests for Hepatitis B, C, and HIV. Women of childbearing potential and partners must use effective birth control during study and one year after last dose, with negative pregnancy tests before starting. Patients need histological diagnosis of specific soft tissue sarcoma types including leiomyosarcoma, malignant peripheral nerve sheath tumor, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, synovial sarcoma, pleomorphic liposarcoma, pleomorphic rhabdomyosarcoma, or unclassified spindle cell sarcoma in arms, legs, or trunk, with primary tumor available for biopsy, measurable tumor by RECIST v1.1, and ECOG performance status 0 or 1.

Main exclusion criteria: Patients without high-grade soft tissue sarcoma in arms, legs, or trunk wall, outside specified age range, unwilling or unable to follow procedures, with other interfering medical conditions, pregnancy or breastfeeding, participation in another trial simultaneously, or recent certain treatments or medications are excluded.

Focus of the trial: The study assesses tumor response to neoadjuvant chemotherapy by monitoring reduction in tumor size using imaging techniques, while evaluating treatment safety and quality of life impact. Researchers collect information to understand treatment mechanisms and identify markers predicting patient response.

Investigational drugs: Ifosfamide is chemotherapy interfering with cancer cell growth and spread. Doxorubicin is chemotherapy slowing or stopping cancer cell growth, used in combination with ifosfamide to enhance treatment effectiveness.

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

This Italian trial investigates pembrolizumab (KEYTRUDA) given intravenously with radiotherapy before surgery, continuing pembrolizumab after surgery, for high-risk soft tissue sarcoma in arms or legs including undifferentiated pleomorphic sarcoma and dedifferentiated/pleomorphic liposarcoma.

Main inclusion criteria: Patients must be 12 years or older with confirmed diagnosis of specific soft tissue sarcoma types verified by pathologist, having tumor size greater than 5 cm. They can have certain other cancer types like non-melanoma skin cancer, early-stage prostate cancer, or in situ carcinoma. Patients need ECOG Performance Status 0 or 1 (fully active or having symptoms but able to do light work), resectable primary tumor with no cancer spread signs, adequate organ function including enough neutrophils, platelets, hemoglobin, normal kidney function measured by creatinine levels, normal liver enzyme levels (ALT and AST), normal bilirubin levels, and enough albumin. Patients must provide written voluntary informed consent, with men and women who can have children agreeing to use effective birth control during study and 120 days after last dose. Women of childbearing potential need negative pregnancy test within 72 hours before starting.

Main exclusion criteria: Patients with different cancer types, tumor size ≤5 cm, tumor grade lower than 2 out of 3, inability to undergo surgery, inability to receive radiotherapy or pembrolizumab, pregnancy or breastfeeding, certain interfering medical conditions, or participation in another trial are excluded.

Focus of the trial: The study compares pembrolizumab with radiotherapy before surgery followed by pembrolizumab after surgery versus radiotherapy alone before surgery. Researchers monitor disease-free survival time, recurrence-free survival, and overall survival through regular follow-up visits including physical examinations, imaging tests, and laboratory tests, with study continuing until 2028.

Investigational drugs: Pembrolizumab helps the body’s immune system fight cancer by blocking the PD-1 pathway, allowing immune system to better target and destroy cancer cells. Radiotherapy uses high-energy rays to kill cancer cells before surgery to shrink tumors and make removal easier.

Study on the Effectiveness of Doxorubicin, Ifosfamide, and Dacarbazine in High-Risk Patients with Resectable Soft-Tissue Sarcoma

This French trial examines adding more chemotherapy before surgery for high-risk resectable soft tissue sarcoma. The study tests whether additional cycles of doxorubicin, dacarbazine, and ifosfamide before surgery improve outcomes compared to standard treatment.

Main inclusion criteria: Patients must have resectable, non-metastatic soft tissue sarcoma confirmed by specialized French expert network. Women of childbearing potential need negative pregnancy tests before joining, with both men and women agreeing to use reliable birth control during study and one year after stopping treatment. Patients must sign written consent, have French law-compliant social security, have cancer classified as Grade 2 or 3 by specific grading system, have tumor sample available for research, not received previous treatment for cancer, be at least 18 years old, have life expectancy of at least 3 months, have ECOG performance status 0 or 1, and have measurable disease by specific criteria.

Main exclusion criteria: Patients with metastatic soft tissue sarcoma (cancer spread to other body parts), not considered high-risk CINSARC, unable to undergo surgery, unable to receive chemotherapy or radiotherapy, under 18 or over 65 years old, or part of vulnerable populations are excluded.

Focus of the trial: Patients receive three cycles of chemotherapy with doxorubicin, followed by surgery. Some receive additional cycles before surgery to see if this improves cancer-free chances. After surgery, patients may receive radiotherapy. Throughout study lasting several years, doctors closely monitor effectiveness, checking for side effects, with results helping understand if intensified chemotherapy approach benefits high-risk soft tissue sarcoma patients.

Investigational drug: Doxorubicin is chemotherapy medication administered intravenously, part of treatment plan for high-risk soft tissue sarcomas. The trial investigates whether adding more doxorubicin cycles before surgery improves outcomes by slowing or stopping cancer cell growth.

Summary

The 23 ongoing clinical trials for soft tissue sarcoma demonstrate a diverse research landscape exploring various treatment approaches across different disease stages. France leads in trial activity with 10 studies, followed by Spain with 9 trials and Italy with 6 studies. This concentration reflects strong European commitment to advancing sarcoma treatment options.

A notable trend is the exploration of immunotherapy combinations, with multiple trials investigating pembrolizumab, nivolumab, and atezolizumab either alone or combined with other treatments including radiotherapy and chemotherapy. Several studies focus specifically on elderly populations, recognizing the unique treatment needs of older patients.

The trials span various treatment settings from resectable tumors requiring preoperative treatment to advanced or metastatic disease. Many studies evaluate novel antibody-drug conjugates and targeted therapies, reflecting the shift toward personalized medicine approaches. Combination strategies involving radiotherapy appear frequently, suggesting interest in enhancing local tumor control while stimulating systemic immune responses.

Significantly, multiple trials include rare sarcoma subtypes such as leiomyosarcoma, malignant peripheral nerve sheath tumors, and specific liposarcoma variants, addressing treatment gaps for these challenging cancers. The research includes both pediatric and adult populations, with some trials accepting patients as young as 6 months to as old as 80 years.

Ongoing Clinical Trials on Soft tissue sarcoma

  • Study of Selinexor and Gemcitabine for Patients with Advanced Soft-Tissue Sarcoma

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Selinexor and Gemcitabine for Patients with Advanced Soft-Tissue Sarcoma

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Safety and Effectiveness of CEB-01 for Children with Resectable Tumors

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Trabectedin and Radiotherapy for Patients with Soft Tissue Sarcoma

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study on Triptorelin for Fertility Protection in Young Women and Teenagers Undergoing Chemotherapy for Breast Cancer, Leukemia, Lymphomas, and Sarcomas

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study of L-Annamycin Treatment for Patients with Previously Treated Metastatic Soft Tissue Sarcoma

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Poland

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

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

  • Study of Cirtuvivint for Patients with Advanced Soft-Tissue Sarcomas as a Second-Line Treatment

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of PM14 Alone and with Radiotherapy for Patients with Advanced Soft Tissue Sarcomas and Other Solid Tumors

    Not recruiting

    1 1
    Investigated diseases:
    Spain

  • Study of BT-001 and Pembrolizumab for Patients with Advanced Solid Tumors, Including Sarcoma, Merkel Cell Carcinoma, Melanoma, Breast, and Lung Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France

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