NCT03523572

Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study of trastuzumab deruxtecan 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 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 maximum tolerated dose/recommended dose for expansion, when used in combination with nivolumab * Part 2 is to assess the efficacy and safety of this dose combination.

Conditions

• Breast Cancer
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	The investigational product is a sterile lyophilized powder, which is made into solution for intravenous administration.
DRUG	Nivolumab	Nivolumab is an aqueous solution formulated at 10 mg/mL to be administered at a flat dose of 360 mg IV over 30 minutes. Protocol-defined thyroid testing is required while taking nivolumab.

Timeline

• Start date: 2018-08-02
• Primary completion: 2021-07-22
• Completion: 2023-09-12
• First posted: 2018-05-14
• Last updated: 2025-01-27
• Results posted: 2025-01-27

Locations

29 sites across 7 countries: United States, Belgium, France, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study