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Protocol No. UW15078

Principal Investigator ORegan, Ruth

Phase I/II

Age Group Adult

Scope Local

Sponsor Type Industry

Title An Open-Label, Single-Arm Multicenter Phase 1b/2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Subjects With Metastatic Triple-Negative Breast Cancer (mTNBC)

Objective The purpose of this study is to evaluate the effectiveness and safety of eribulin mesylate (“eribulin”) in combination with pembrolizumab in metastatic (where the cancer has spread from one part of body to another) triple-negative breast cancer (mTNBC). The combination of eribulin and pembrolizumab is investigational. Each of the two study drugs (eribulin and pembrolizumab), when given separately, work in different ways to stop the cancer cells from growing and spreading. With different mechanisms of action, the combination of eribulin and pembrolizumab might work together to stop the cancer cells from growing and spreading. The purpose of the study is to see if there is any shrinkage of your tumor and for how long any effect on your tumor lasts.

Treatment Eribulin (also known as HALAVEN®) is approved by the FDA (the U.S. Food and Drug Administration) to treat patients with metastatic breast cancer and liposarcoma, a rare cancer of connective tissues, and may be used as a treatment option for your disease. Eribulin is developed from a natural substance found in a sea sponge. Eribulin works by preventing cancer cells from multiplying. Pembrolizumab (also known as KEYTRUDA®) is an FDA-approved drug used to treat patients with metastatic melanoma, a type of skin cancer, and a certain type of metastatic non-small cell lung cancer (NSCLC). It is also being investigated for the treatment of other cancers. Pembrolizumab is a medicine that may treat cancer by working with your immune system.

Description This is a phase 1b/2 clinical study. The first part of this study (phase 1b) is designed to determine the highest, safest dose of eribulin that can be given in combination with a specifically selected dose of pembrolizumab. The second part of this study (phase 2) is designed to test the two drug combination using these doses for how well it treats your type of cancer. Pembrolizumab is given by an injection into your vein. Each pembrolizumab dose is given over approximately 30 minutes on Day 1 of a 21-dayion using these doses for how well it treats your type of cancer. Eribulin is given by an injection into your vein (known as an intravenous, or IV, infusion).Each eribulin dose is given over a short period of 2 to 5 minutes once a week for 2 weeks (on Day 1 and Day 8 of a 21- day cycle), followed by 1 week off.

Key Eligibility
  • Metastatic triple-negative breast cancer that has been previously treated with 0 to 2 lines of systemic anticancer therapy (cytotoxicor targeted anticancer agents) in the metastatic setting
  • Presence of measureable disease
  • Females must not be lactating or pregnant
  • Patients with previous treatment with eribulin mesylate or any anti-PD-1, PD-L1, PD-L2 agent are ineligible
  • Patients with active autoimmune disease that has required systemic treatment in the past 2 years are ineligible
  • Patients are ineligible if it has been less than 6 months since prior adjuvant chemotherapy
  • Patients who have had treatment with chemotherapy or biological therapy within the previous 3 weeks, radiation or small molecule targeted therapy within the previous 2 weeks are ineligible
  • Patients with known history of HIV positive, active hepatitis B, or hepatitis C are ineligible
  • Patients who are scheduled for major surgery during the study are ineligible
  • Patients who have a history of interstitial lung disease are ineligible

Applicable Disease Sites Breast

Therapies Involved Cytotoxic Chemotherapy; Immunotherapy

Drugs Involved Halaven (eribulin); Keytruda (pembrolizumab); MK-3475 (pembrolizumab); eribulin; pembrolizumab

Status Open

Participating Institutions UW Hospital and Clinics