Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
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.
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
Quick Facts
Study Start:2024-07-19
Study Completion:2029-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Contacts and Locations
Study Locations (Sites)
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124
United States
AdventHealth Hematology and Oncology
Orlando, Florida, 32804
United States
Winship Cancer Institute
Atlanta, Georgia, 30322
United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
United States
Norton Cancer Institute - Audubon
Louisville, Kentucky, 40217
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, 55369
United States
Atlantic Health System/Morristown Medical Center
Morristown, New Jersey, 07960
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Centers
New York, New York, 10022
United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Texas Oncology - DFW
Dallas, Texas, 75246
United States
The Univerrsity of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Collaborators and Investigators
Sponsor: Jazz Pharmaceuticals
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2024-07-19
Study Completion Date2029-11-01
Study Record Updates
Study Start Date2024-07-19
Study Completion Date2029-11-01
Terms related to this study
Keywords Provided by Researchers
- JZP598
- ZW25
- HER-2 positive BIliary Tract cancer
- Gallbladder Cancer
- Intrahepatic Cholangiocarcinoma (ICC)
- Extrahepatic Cholangiocarcinoma (ECC)
- Zanidatamab
Additional Relevant MeSH Terms
- Biliary Tract Cancer
- HER2 Gene Mutation