Last updated on August 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 a recommended phase 2 dose for 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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Virginia Piper Cancer Institute

Minneapolis, MN United States
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