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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03899805
Phase
PHASE2
Status
Completed

Conditions

  • Leiomyosarcoma
  • Liposarcoma
  • Sarcoma
  • Undifferentiated Pleomorphic Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Eribulin — DRUG
    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).
  • Pembrolizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 4, 2019
Status verified
Aug 2025
Primary completion
Jul 16, 2024
Completion
Jul 16, 2024

Study Design

Enrollment
57 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liposarcomas
    * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle
  • Experimental: Leiomyosarcomas
    * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle
  • Experimental: Undifferentiated Pleomorphic sarcomas
    * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle

Primary Outcome Measure

12-week Progression Free Survival (PFS) [ Time Frame: 12 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

Related coverage on Hipa.ai

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By research site
Dana Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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