Ongoing Clinical Trials for Liposarcoma
There are currently 2 clinical trials investigating new treatment options for liposarcoma and related soft tissue sarcomas. These studies are being conducted across several European countries including Denmark, Sweden, Norway, and Germany, testing different combinations of targeted therapies and immunotherapies for patients with advanced or metastatic disease who have not responded well to previous treatments.
Clinical trial locations
- Denmark
- Germany
- Norway
- Sweden
Study of Pemigatinib and Retifanlimab for Patients with Advanced Dedifferentiated Liposarcoma
This clinical trial is investigating the effectiveness of two medications for patients with advanced dedifferentiated liposarcoma, a rare form of cancer that develops in fat cells. The study is being conducted in Denmark, Sweden, and Norway and is expected to conclude by April 2027.
Main inclusion criteria: To participate in this study, patients must be 18 years of age or older and have a confirmed diagnosis of dedifferentiated liposarcoma with positive results for MDM2 immunohistochemistry or MDM2 amplification. Participants must have at least one tumor that can be measured using imaging scans and cannot be removed by surgery. Patients must be willing to provide a tumor tissue sample through a biopsy at specific times during the study, though previous archived samples can be used if available. Participants should also have a performance status of 0-2 on the ECOG Performance Scale, which measures how well a person can perform daily activities.
Main exclusion criteria: Patients who have a different type of cancer than dedifferentiated liposarcoma cannot participate. Those who are pregnant or breastfeeding, have serious health conditions that might interfere with the study, or have allergies or reactions to the study medications are not eligible. Patients who have recently participated in another clinical trial or who cannot understand or follow the study procedures will also be excluded.
Focus and goal: The study aims to evaluate the potential benefits of combining two different treatment approaches: Pemigatinib, a tablet that targets specific pathways in cancer cells involved in their growth and survival, and Retifanlimab, an intravenous infusion designed to help the immune system recognize and attack cancer cells. The trial will monitor disease progression over time, assessing how long patients live without the disease getting worse and how their bodies respond to the treatments. Researchers will also track overall survival, side effects, changes in quality of life, and patients’ ability to perform daily activities using questionnaires.
Investigational drugs: Pemigatinib is administered orally in the form of 4.5 mg tablets and works by inhibiting fibroblast growth factor receptors, which are involved in the growth and spread of cancer cells. It is classified as a targeted cancer therapy. Retifanlimab is administered intravenously and functions as an immune checkpoint inhibitor, blocking a protein called PD-1 on immune cells to enhance the body’s immune response against cancer cells.
Study of Trabectedin alone versus Trabectedin with tTF-NGR combination therapy in adults with metastatic or refractory soft tissue sarcoma who failed first-line treatment
This clinical trial, being conducted in Germany, studies treatment options for soft tissue sarcoma, including liposarcoma, in patients whose cancer has spread to other parts of the body or who did not respond well to previous treatments. The study is expected to continue until March 2029.
Main inclusion criteria: Eligible participants must be between 18 and 75 years of age and have advanced or metastatic soft-tissue sarcoma that either did not respond to previous treatment with anthracycline medications or where anthracyclines cannot be used for medical reasons. Patients must have confirmed high-grade soft tissue sarcoma, including various types of liposarcoma such as dedifferentiated, myxoid, pleomorphic, or round cell types. The tumor must test positive for CD13, a specific protein marker, with a score of 1 or higher. Participants must have at least one measurable tumor that has not been previously treated with radiation and a life expectancy of at least 3 months. Women who can become pregnant must have a negative pregnancy test and use effective birth control during the study and for 3 months after, while men must use birth control methods for 5 months after the last treatment.
Main exclusion criteria: Patients younger than 18 or older than 75 years cannot participate. Those who are currently pregnant or breastfeeding, have severe heart, liver, or kidney problems, active uncontrolled infections, or other active cancers requiring treatment are not eligible. Patients who have previously been treated with trabectedin, have known allergic reactions to the study medications, or tested negative for the CD13 protein marker will be excluded. Those who have participated in another clinical trial within the past 30 days or are unable to provide informed consent are also ineligible.
Focus and goal: The study compares two treatment approaches: one using only trabectedin, a chemotherapy medication, and another combining trabectedin with tTF-NGR, an experimental drug. The goal is to determine if adding tTF-NGR to standard trabectedin treatment helps keep the cancer under control for a longer time. The experimental drug tTF-NGR is designed to concentrate the chemotherapy medication inside the tumor, potentially making the treatment more effective. Both medications are given through intravenous infusion directly into the bloodstream. Participants will receive treatment for up to 360 days, with regular medical examinations and imaging tests to monitor how the cancer responds.
Investigational drugs: Trabectedin is a marine-derived anti-cancer medication that works by binding to DNA and interfering with cell division, transcription, and DNA repair mechanisms in cancer cells, effectively stopping tumor growth. tTF-NGR is an experimental therapeutic compound designed to work in combination with trabectedin by helping to trap the medication inside the tumor tissue, potentially increasing its local concentration and therapeutic effect.
Summary
Currently, there are two active clinical trials offering new treatment options for patients with liposarcoma. The first trial focuses specifically on dedifferentiated liposarcoma and is available across three Scandinavian countries: Denmark, Sweden, and Norway. It tests a combination of targeted therapy and immunotherapy using pemigatinib and retifanlimab. The second trial, conducted in Germany, includes various types of liposarcoma as part of a broader study on soft tissue sarcomas and compares standard chemotherapy with trabectedin alone versus a combination of trabectedin with the experimental agent tTF-NGR.
Both studies target patients with advanced disease who have not responded well to previous treatments. The Scandinavian trial requires MDM2 positivity testing, while the German study requires CD13 positivity testing. The approaches differ significantly: one focuses on combining targeted therapy with immunotherapy to enhance the immune system’s ability to fight cancer, while the other aims to improve the effectiveness of chemotherapy by concentrating it within tumor tissue. These trials represent different strategies in addressing the challenges of treating advanced liposarcoma and related soft tissue sarcomas.
