NCT03899805

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Sarcoma
• Liposarcoma
• Leiomyosarcoma
• Undifferentiated Pleomorphic Sarcoma

Interventions

Type	Name	Description
DRUG	Eribulin	The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis).
DRUG	Pembrolizumab	The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.

Timeline

• Start date: 2019-06-04
• Primary completion: 2024-07-16
• Completion: 2024-07-16
• First posted: 2019-04-02
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study