Spots Global Cancer Trial Database for Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer
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Trial Identification
Brief Title: Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer
Official Title: 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
Study ID: NCT03523572
Study Description
Brief Summary: 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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
AZ Groeninge, Kortrijk, West-Vlaanderen, Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
GZA Hospital Campus Sint-Augustinus, Wilrijk, , Belgium
Institut de Cancerologie de L'Ouest, Angers, , France
Centre Georges Francois Leclerc, Dijon, , France
ICO Rene Gauducheau, Saint-Herblain, , France
Charite Campus Benjamin Franklin, Berlin, Brandenburg, Germany
University Hospital Frankfurt, Frankfurt, Hessen, Germany
University Cancer Center, Dresden, Sachsen, Germany
Ospedale San Raffaele, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Azienda Ospedaliera Universitaria Senese U.O.C. Immunoterapia Oncologica, Siena, , Italy
Hospital Gregorio Maranon Madrid Spain, Madrid, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Universitario Ramon y Cajal Madrid, Madrid, , Spain
Fundacion Jimenez Diaz, Madrid, , Spain
START Madrid CIOCC, Madrid, , Spain
Sarah Cannon Research Institute UK, London, England, United Kingdom
Royal Marsden Hospital (Surrey), London Borough of Sutton, , United Kingdom
Contact Details
Name: Global Team Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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