180
Participants
Start Date
June 20, 2024
Primary Completion Date
October 16, 2029
Study Completion Date
October 16, 2029
Sacituzumab tirumotecan
Given by IV infusion.
Fluorouracil (5-FU)
5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.
Leucovorin (LV) or levoleucovorin
LV or levoleucovorin is administered by IV infusion every 2 weeks.
Rescue medication
Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.
Supportive care measures
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as a supportive care for Ocular Surface Toxicity.
Cisplatin
Given by IV infusion.
Pembrolizumab
Given by IV infusion.
RECRUITING
Taipei Veterans General Hospital ( Site 0221), Taipei
RECRUITING
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224), Tainan City
RECRUITING
Hôpitaux Universitaires de Genève (HUG) ( Site 0202), Geneva
RECRUITING
Westmead Hospital ( Site 0003), Westmead
RECRUITING
Epworth Freemasons ( Site 0005), East Melbourne
RECRUITING
Frankston Hospital-Oncology and Haematology ( Site 0004), Frankston
RECRUITING
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001), Brisbane
RECRUITING
One Clinical Research ( Site 0002), Nedlands
RECRUITING
Ospedale Regionale Bellinzona e Valli ( Site 0201), Bellinzona
RECRUITING
National Taiwan University Hospital-Oncology ( Site 0225), Taipei
RECRUITING
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324), New York
RECRUITING
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327), Mineola
RECRUITING
Sibley Memorial Hospital ( Site 0310), Washington D.C.
RECRUITING
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101), Milan
RECRUITING
ASST Grande Ospedale Metropolitano Niguarda ( Site 0102), Milan
RECRUITING
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295), Roanoke
RECRUITING
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183), Madrid
COMPLETED
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303), Marietta
RECRUITING
University of Florida College of Medicine ( Site 0281), Gainesville
RECRUITING
Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182), Oviedo
RECRUITING
Mount Sinai Cancer Center ( Site 0287), Miami Beach
RECRUITING
Chang Gung Medical Foundation-Linkou Branch ( Site 0222), Taoyuan District
RECRUITING
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293), Madison
RECRUITING
University of Texas MD Anderson Cancer Center ( Site 0316), Houston
RECRUITING
University of Colorado Anschutz Medical Campus ( Site 0299), Aurora
RECRUITING
University of Colorado Anschutz Medical Campus ( Site 0325), Aurora
RECRUITING
University of Colorado Anschutz Medical Campus ( Site 0326), Aurora
RECRUITING
UCLA ( Site 0317), Los Angeles
RECRUITING
Beijing Cancer hospital-Digestive Oncology ( Site 0061), Beijing
RECRUITING
Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067), Shanghai
RECRUITING
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063), Fuzhou
RECRUITING
China Medical University Hospital ( Site 0223), Taichung
RECRUITING
Hunan Cancer Hospital-intervention department ( Site 0066), Changsha
RECRUITING
Wuhan Union Hospital Cancer Center. ( Site 0064), Wuhan
RECRUITING
West China Hospital, Sichuan University ( Site 0068), Chengdu
RECRUITING
James Lind Centro de Investigacion del Cancer ( Site 0048), Temuco
RECRUITING
FALP-UIDO ( Site 0041), Providencia
RECRUITING
Clínica UC San Carlos de Apoquindo ( Site 0043), Santiago
RECRUITING
Bradfordhill-Clinical Area ( Site 0047), Santiago
RECRUITING
The Ottawa Hospital Cancer Centre ( Site 0027), Ottawa
RECRUITING
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022), Montreal
RECRUITING
McGill University Health Centre ( Site 0023), Montreal
RECRUITING
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103), Roma
RECRUITING
National Cancer Center Hospital East ( Site 0121), Kashiwa
RECRUITING
Kanagawa Cancer Center ( Site 0122), Yokohama
RECRUITING
Seoul National University Hospital ( Site 0161), Seoul
RECRUITING
Severance Hospital, Yonsei University Health System ( Site 0164), Seoul
RECRUITING
Asan Medical Center ( Site 0163), Seoul
RECRUITING
Samsung Medical Center ( Site 0162), Seoul
RECRUITING
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181), Barcelona
RECRUITING
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241), Ankara
RECRUITING
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242), Ankara
RECRUITING
Barts Health NHS Trust ( Site 0263), London
RECRUITING
Royal Free Hospital ( Site 0262), London
RECRUITING
University Hospital Coventry & Warwickshire ( Site 0266), Coventry
Merck Sharp & Dohme LLC
INDUSTRY