Clinical Trials for Metastatic Sarcoma
There are currently 4 ongoing clinical trials for patients with metastatic sarcoma, investigating combinations of immunotherapy and chemotherapy treatments. These studies are being conducted in France, Spain, and Poland, offering treatment options for patients with advanced soft tissue sarcomas and bone tumors.
Clinical trial locations
- France
- Poland
- Spain
Study of Bintrafusp Alfa and Doxorubicin Hydrochloride for Adults with Advanced Soft-Tissue Sarcoma
This trial is investigating a combination of two medications for patients with advanced soft tissue sarcoma: Bintrafusp alfa and Doxorubicin hydrochloride. Both medications are given through an intravenous infusion directly into the bloodstream.
Main inclusion criteria: Participants must be adults aged 18 years or older with advanced or inoperable soft tissue sarcoma confirmed by a specialized review process. They need to have good organ function, including adequate blood counts, liver and kidney function. Women of childbearing potential must have a negative pregnancy test, and both men and women must use effective birth control during the study. Patients must have measurable disease, a life expectancy of more than 3 months, and be willing to provide tumor samples for research purposes. No previous treatment for advanced or metastatic disease is allowed.
Main exclusion criteria: The trial excludes patients with different types of cancer than the one being studied, those who have had recent cancer treatment, people with serious heart problems or uncontrolled infections, pregnant or breastfeeding women, those with allergies to the study drugs, patients with severe allergic reaction history, organ transplant recipients, people with autoimmune diseases, those taking immune system medications, patients with drug or alcohol abuse history, and those unable to follow study procedures.
Study focus: The main goal is to evaluate how effective the combination of Bintrafusp alfa and Doxorubicin hydrochloride is in controlling the disease. Bintrafusp alfa works by targeting specific proteins that suppress the immune response, helping the body’s natural defenses fight cancer cells. Doxorubicin hydrochloride is a chemotherapy drug that interferes with cancer cell DNA, preventing them from growing and dividing. Throughout the trial, patients will undergo regular assessments to track tumor response and disease progression.
Study of Trabectedin and Low-Dose Radiation Therapy for Adults and Young Adults with Advanced or Metastatic Soft Tissue and Bone Sarcomas
This study combines Trabectedin, a chemotherapy medication given through intravenous infusion, with low-dose radiation therapy. The trial includes patients with three types of sarcomas: soft tissue sarcoma, bone tumors including osteosarcoma and chondrosarcoma, and small round-cell sarcomas such as Ewing’s sarcoma and rhabdomyosarcoma.
Main inclusion criteria: Patients must be between 16 and 75 years old with advanced or metastatic sarcoma that cannot be surgically removed. They should have a performance status of 1 or less, meaning they can carry out light activities. Good respiratory function is required for those with lung-related tumors. Patients need healthy bone marrow function with adequate blood cell counts, normal levels of blood substances like creatinine and liver enzymes, and normal heart function. A central venous catheter is necessary for medication administration. The disease must have progressed in the last 6 months, and patients must be eligible for chemotherapy with at least one but no more than three previous treatments for advanced cancer.
Main exclusion criteria: The trial excludes patients without confirmed advanced soft tissue sarcoma, bone tumors, or small round-cell sarcomas, those without measurable disease, and individuals who are not adults or young adults.
Study focus: The primary goal is to determine how well tumors respond to the combination of Trabectedin and radiation therapy, particularly in areas receiving radiation. Trabectedin interferes with cancer cell growth, slowing their spread throughout the body. Low-dose radiation therapy uses high-energy rays to target and destroy cancer cells while minimizing damage to surrounding healthy tissue. The study will monitor tumor size changes, treatment effectiveness duration, and effects on pain levels and overall well-being.
Study of L-Annamycin Treatment for Patients with Previously Treated Metastatic Soft Tissue Sarcoma
This trial evaluates Liposomal Annamycin, a medication given through weekly intravenous administration. The study focuses on patients who have already received previous treatment, including prior anthracycline therapy.
Main inclusion criteria: Patients must be 18 years or older with confirmed metastatic soft tissue sarcoma that cannot be cured with surgery. They need an ECOG performance status of 2 or less with a life expectancy greater than 3 months. At least one measurable tumor larger than 10 millimeters is required. Patients must have previously received anthracycline therapy and shown disease progression, with at least 2 weeks since their last treatment and side effects resolved. Adequate blood test results are necessary, including sufficient white blood cells, platelets, hemoglobin level of 8.0 g/dL or higher, good kidney function, and normal or near-normal liver function. Effective birth control must be used during the study and for 6 months afterward.
Main exclusion criteria: The trial excludes patients with a history of allergic reactions to similar drugs, brain metastases unless treated and stable for at least 4 weeks, heart problems including heart failure or heart attack within the last 6 months, severe liver or kidney problems, active uncontrolled infections, other cancers within the last 3 years, blood disorders affecting blood cell counts, participation in other trials within 4 weeks, pregnancy or breastfeeding, and those unable to use effective birth control.
Study focus: The research aims to test how well patients tolerate weekly Liposomal Annamycin and how effective it is in treating metastatic soft tissue sarcomas. The study is divided into two parts: finding the right safe dose and examining treatment effectiveness. Liposomal Annamycin is a chemotherapy drug modified with a special coating to improve its performance and potentially reduce side effects while maintaining effectiveness against cancer cells.
Study on Retifanlimab, Doxorubicin, and Ifosfamide for Adults with Certain Types of Sarcoma in the Abdomen, Limbs, and Trunk
This trial investigates a treatment combining Retifanlimab with standard chemotherapy drugs Doxorubicin and Ifosfamide. All medications are delivered through intravenous infusion directly into the bloodstream. The study focuses on retroperitoneal sarcoma, which occurs in the area behind the abdominal organs, as well as in the limbs and trunk wall.
Main inclusion criteria: Patients must be 18 years or older with undifferentiated pleomorphic sarcoma in the limbs, trunk wall, or retroperitoneum, confirmed by a specialized network. The disease must be measurable with at least one tumor visible on CT scan. Normal blood, kidney, liver, and thyroid function is required, along with heart pumping ability of at least 50%. Women of childbearing potential need a negative pregnancy test and must agree to use effective birth control during and after the study. Any side effects from previous treatments must have improved to mild levels. The cancer must not have spread to other body parts and must be surgically removable. There must be at least one tumor available for biopsy. No previous treatment for the current cancer is allowed, and patients must have a life expectancy of more than 3 months.
Main exclusion criteria: The study excludes patients who have already received treatment for their sarcoma, those with metastatic or unresectable sarcomas, non-adults, and vulnerable populations requiring special protection or care.
Study focus: The purpose is to explore how effective this combination treatment is in reducing tumor size before surgery. Retifanlimab is an investigational medication that helps the body’s immune system fight cancer by targeting and inhibiting specific proteins on immune cells. Doxorubicin is a chemotherapy drug that slows or stops cancer cell growth, while Ifosfamide interferes with cancer cell DNA, preventing growth and division. The tumor response will be assessed by examining tissue removed during surgery, and the study will also monitor treatment safety and how long patients remain free from cancer progression.
Summary
The four ongoing clinical trials for metastatic sarcoma demonstrate a clear focus on combination therapies that pair newer immunotherapy approaches with established chemotherapy treatments. The studies are geographically concentrated in Europe, with France hosting two trials, while Spain and Poland each host one.
A notable pattern across these trials is the investigation of Doxorubicin, a well-established chemotherapy drug, in combination with novel immunotherapy agents in two separate studies. The trials show diversity in treatment approaches, ranging from combining immunotherapy with chemotherapy to pairing chemotherapy with radiation therapy.
Most trials require patients to have measurable disease and adequate organ function, particularly heart, liver, and kidney function. Several studies accept patients who have received previous treatment, though they typically limit the number of prior therapies allowed. The trials also share common safety measures, including requirements for effective contraception during and after treatment.
These studies offer hope for patients with advanced sarcomas, particularly those who have exhausted standard treatment options, by testing innovative combinations that may improve treatment outcomes while managing side effects.
