Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

August 2, 2018

Primary Completion Date

July 22, 2021

Study Completion Date

September 12, 2023

Conditions
Breast CancerUrothelial Carcinoma
Interventions
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.

Trial Locations (29)

1200

Cliniques Universitaires Saint-Luc, Brussels

2610

GZA Hospital Campus Sint-Augustinus, Wilrijk

8500

AZ Groeninge, Kortrijk

10029

Icahn School of Medicine at Mount Sinai, New York

12200

Charite Campus Benjamin Franklin, Berlin

20132

Ospedale San Raffaele, Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

21079

Centre Georges Francois Leclerc, Dijon

28007

Hospital Gregorio Maranon Madrid Spain, Madrid

28033

MD Anderson Cancer Center Madrid, Madrid

28034

Hospital Universitario Ramon y Cajal Madrid, Madrid

28040

Fundacion Jimenez Diaz, Madrid

28050

START Madrid CIOCC, Madrid

28204

Levine Cancer Institute Carolinas Healthcare System, Charlotte

33136

University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center, Miami

37203

Tennessee Oncology - Sara Cannon Research Institute, Nashville

40202

Norton Cancer Institute, Louisville

44718

Gabrail Cancer Center Research, Canton

44805

ICO Rene Gauducheau, Saint-Herblain

49055

Institut de Cancerologie de L'Ouest, Angers

53100

Azienda Ospedaliera Universitaria Senese U.O.C. Immunoterapia Oncologica, Siena

60590

University Hospital Frankfurt, Frankfurt am Main

84112

Huntsman Cancer Institute, Salt Lake City

90404

UCLA - Medical Center, Santa Monica

98109

University of Washington Medical Center, Seattle

06520

Yale University, New Haven

01307

University Cancer Center, Dresden

W1G6AD

Sarah Cannon Research Institute UK, London

SM25PT

Royal Marsden Hospital (Surrey), Sutton

Sponsors
All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

AstraZeneca

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY