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This research study is studying a combination of drugs (chemotherapy + Immunotherapy) as a possible treatment for liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma that has spread and has not responded to standard treatment.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug, or in the case of this study, combination of drugs, to learn whether the combination of drugs works in treating a specific disease. "Investigational" means that the combination of drugs is being studied. The primary purpose of this research study is to test the safety and effectiveness of eribulin and pembrolizumab in combination for controlling this cancer The FDA (the U.S. Food and Drug Administration) has approved eribulin for the treatment of liposarcoma, based on a phase III study that compared eribulin and dacarbazine in the treatment of liposarcoma and leiomyosarcoma. The FDA has not approved pembrolizumab for this specific disease but it has been approved for other uses. A phase II study showed rare responses of liposarcoma and undifferentiated pleomorphic sarcoma to treatment with pembrolizumab. While eribulin in combination with pembrolizumab has not previously been tested in the treatment of liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma, other research studies and laboratory experiments and information from those studies suggest that the combination of these drugs may help to stop cancer cells from growing. Chemotherapy treatment with eribulin may increase the response to immunotherapy with pembrolizumab
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Start Date
June 4, 2019
Primary Completion Date
July 16, 2024
Completion Date
July 16, 2024
Last Updated
August 28, 2025
57
ACTUAL participants
Eribulin
DRUG
Pembrolizumab
DRUG
Lead Sponsor
Dana-Farber Cancer Institute
Collaborators
NCT04704661
NCT06066138
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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