Last updated on January 2019

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 in combination with pembrolizumab to find out what their side effects are and if they work for patients with triple-negative breast cancer that has spread to other parts of the body. Patients will be given both experimental drugs every 3 weeks.

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 in Part A will be monitored for frequency of dose-limiting toxicities to determine if SGN-LIV1A dosing should be de-escalated before opening the expansion in Part B. 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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Ursa Brown-Glaberman, MD

University of New Mexico Cancer Center
Albuquerque, NM United States
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Ritesh Parajuli

Chao Family Comprehensive Cancer Center University of California Irvine
Orange, CA United States
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Michael Guarino

Helen F. Graham Cancer Center / Christiana Care Health Systems
Newark, DE United States
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Kimberly Kruczek

Ingalls Cancer Care / Ingalls Memorial Hospital
Harvey, IL United States
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Katherine H. R. Tkaczuk

University of Maryland
Baltimore, MD United States
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Michaela Tsai

Virginia Piper Cancer Institute
Minneapolis, MN United States
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Adam Brufsky

Hillman Cancer Center / University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Carlos Alemany

Cancer Institute of Florida
Orlando, FL United States
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Jane Meisel

Winship Cancer Institute / Emory University School of Medicine
Atlanta, GA United States
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Steven Papish

Summit Medical Group
Florham Park, NJ United States
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Ritesh Parajuli

University of California Irvine - Newport
Orange, CA United States
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Kathy Albain

Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, IL United States
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Michelina Cairo

Texas Oncology - Houston Memorial City
Houston, TX United States
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Timothy Pluard

Saint Luke's Cancer Institute LLC
Kansas City, MO United States
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Joyce O'Shaughnessy

Texas Oncology - Baylor Sammons Cancer Center
Dallas, TX United States
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Linda Vahdat

The Whittingham Cancer Center / Norwalk Hospital
Norwalk, CT United States
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Hyo Heather Han

H. Lee Moffitt Cancer Center and Research Institute
Tampa, FL United States
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Eleni Andreopoulou

Weill Cornell Medical College
New York, NY United States
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Patrick Dillon

University of Virginia
Charlottesville, VA United States
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Erica Stringer-Reasor

University of Alabama at Birmingham
Birmingham, AL United States
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Recruitment Status: Open

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