M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen bySenthilkumar Damodaran

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase Ib trial studies the best dose and side effects of eribulin mesylate when given together with M7824)in treating patients with triple negative breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as M7824, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving eribulin mesylate and M7824 may work better at treating triple negative breast cancer.

Research Team

Senthilkumar Damodaran

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Inclusion Criteria

Signed written informed consent.

Histologically confirmed metastatic triple negative breast cancer with measurable disease by RECIST 1.1 criteria

Hormone receptor (HR) defined as positive for the purposes of this study, if expression of estrogen receptor (ER) and/or progesterone receptor (PR) expression is greater than 10% by immunohistochemistry (IHC) and HER2 negative or non-amplified is determined by the current American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) criteria, which are as follows: HER2 testing by IHC as 0 or 1+. If HER2 is 2+, ISH (in situ hybridization) must be performed.

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Treatment Details

Interventions

Eribulin Mesylate (Microtubule Inhibitor)
M7824 (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (bintrafusp alfa, eribulin mesylate)Experimental Treatment2 Interventions

Patients receive bintrafusp alfa IV over 50-80 minutes on days 1, 15, and 29, and eribulin mesylate IV over 2-5 minutes on days 1, 8, 22, and 29. Treatment repeats every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Eribulin Mesylate is already approved in Canada, Japan for the following indications: