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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UCLA - Medical Center
Santa Monica, California, United States
Yale University
New Haven, Connecticut, United States
University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Levine Cancer Institute Carolinas Healthcare System
Charlotte, North Carolina, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Tennessee Oncology - Sara Cannon Research Institute
Nashville, Tennessee, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Washington Medical Center
Seattle, Washington, United States
Start Date
August 2, 2018
Primary Completion Date
July 22, 2021
Completion Date
September 12, 2023
Last Updated
January 27, 2025
86
ACTUAL participants
Trastuzumab deruxtecan
DRUG
Nivolumab
DRUG
Lead Sponsor
Daiichi Sankyo
Collaborators
NCT05673200
NCT05372640
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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