Last updated on April 2019

Trastuzumab Deruxtecan (DS-8201a) With Nivolumab in Advanced Breast and Urothelial Cancer


Brief description of study

This is a study of DS-8201a, which is an experimental drug not approved yet by the FDA.

Participants will receive this study drug along with a cancer drug that is already being used, 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 (Phase 1/Phase 2) study is to assess the combination of a test drug (DS-8201a) 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 DS-8201a 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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Recruitment Status: Open


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