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A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas

Sarcoma Clinical Trial

Official title:
A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03899805
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 13, 2019
Completion date August 1, 2025
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