Last updated on June 2020

Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer


Brief description of study

This trial studies SGN-LIV1A with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if the drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.

Detailed Study Description

The primary goal of this study is to evaluate the combination of SGN-LIV1A, which targets LIV-1- expressing tumor cells, with the checkpoint inhibitor pembrolizumab for patients with unresectable locally-advanced or metastatic triple-negative breast cancer. These two drugs act through distinct and possibly complementary modes of action.

This is a single-arm, open-label, multicenter trial. Patients given SGN-LIV1A and pembrolizumab during dose escalation will be monitored for frequency of dose-limiting toxicities to determine a recommended doses for expansion cohorts. In addition to safety measures, objective response rate, progression-free survival, overall survival, and other efficacy outcomes will be assessed.

Clinical Study Identifier: NCT03310957

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Saint Luke's Cancer Institute LLC

Kansas City, MO United States
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Virginia Piper Cancer Institute

Minneapolis, MN United States
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University of Virginia

Charlottesville, VA United States
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University of Maryland

Baltimore, MD United States
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Piedmont Cancer Institute

Atlanta, GA United States
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Summit Medical Group

Florham Park, NJ United States
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Institut Catala D'oncologia

L'Hospitalet de Llobregat, Spain
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Weill Cornell Medicine

New York, NY United States
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CHA Bundang Medical Center

Seongnam, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Weill Cornell Medicine

New York, NY United States
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Recruitment Status: Open


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