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Brief Title: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Official Title: An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer
Study ID: NCT06282575
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Rocky Mountain Cancer Centers, LLP, Lone Tree, Colorado, United States
Norton Cancer Institute - Audubon, Louisville, Kentucky, United States
Minnesota Oncology Hematology, P.A., Maple Grove, Minnesota, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
Texas Oncology - DFW, Dallas, Texas, United States
Hospital Oncologico, Puerto Rico Medical Center, Rio Piedras, , Puerto Rico