Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract 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.

Conditions

Biliary Tract Cancer, HER2 Gene Mutation

Study Overview

Study Details

Study overview

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.

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

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

Condition
Biliary Tract Cancer
Intervention / Treatment

-

Contacts and Locations

Lone Tree

Rocky Mountain Cancer Centers, LLP, Lone Tree, Colorado, United States, 80124

Orlando

AdventHealth Hematology and Oncology, Orlando, Florida, United States, 32804

Atlanta

Winship Cancer Institute, Atlanta, Georgia, United States, 30322

Westwood

The University of Kansas Cancer Center - Westwood, Westwood, Kansas, United States, 66205

Louisville

Norton Cancer Institute - Audubon, Louisville, Kentucky, United States, 40217

New Orleans

Ochsner Clinic Foundation, New Orleans, Louisiana, United States, 70121

Ann Arbor

University of Michigan Hospital, Ann Arbor, Michigan, United States, 48109

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

Maple Grove

Minnesota Oncology Hematology, P.A., Maple Grove, Minnesota, United States, 55369

Morristown

Atlantic Health System/Morristown Medical Center, Morristown, New Jersey, United States, 07960

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Jazz Pharmaceuticals,

    Study Record Dates

    2029-11-01