Last updated on May 2020

Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer


Brief description of study

This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens.

Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab.

The study will be done in two parts:

  • Part 1 is to identify the recommended dose to use for treatment.
  • Part 2 is to find out how well the combination works, and how safe and tolerable it is.

Detailed Study Description

The purpose of this phase 1b (Part 1, Part 2) study is to assess the combination of a test drug (trastuzumab deruxtecan) with nivolumab in participants with HER2-expressing breast and urothelial cancer who had disease progression during or after prior therapies, did not respond to standard therapies, or for whom no standard therapy is available.

The study will be performed in 2 parts.

  • Part 1 is to test different doses of trastuzumab deruxtecan when given along with a fixed dose of nivolumab, and establish the most effective and the maximum/recommended tolerated dose, when used in combination with nivolumab
  • Part 2 is to assess the efficacy and safety of this dose combination.

Clinical Study Identifier: NCT03523572

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UCLA - Medical Center

Santa Monica, CA United States
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Yale University

New Haven, CT United States
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Norton Cancer Institute

Louisville, KY United States
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Huntsman Cancer Institute

Salt Lake City, UT United States
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Royal Marsden Hospital (Surrey)

London Borough of Sutton, United Kingdom
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AZ Groeninge

Kortrijk, Belgium
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ICO Rene Gauducheau

Saint-Herblain, France
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