protocolSection identificationModule nctId: NCT06282575, orgStudyIdInfo id: JZP598-302, secondaryIdInfos id: 2023-508219-21-00, type: OTHER, domain: CTIS, briefTitle: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2028-07-01, completionDateStruct date: 2029-11-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Jazz Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Biliary Tract Cancer, conditions: HER2 Gene Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 286, type: ESTIMATED, armsInterventionsModule interventions name: Zanidatamab, interventions name: Cisplatin, interventions name: Gemcitabine, interventions name: Pembrolizumab, interventions name: Durvalumab, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors, secondaryOutcomes measure: Overall survival (OS) in participants with IHC 3+ tumors, secondaryOutcomes measure: Progression Free Survival for all participants, secondaryOutcomes measure: OS for all participants, secondaryOutcomes measure: Number of participants achieving Confirmed objective response rate (cORR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Number of Patients reporting Treatment-Emergent Adverse Events (TEAE), secondaryOutcomes measure: Maximum serum concentration of Zanidatamab, secondaryOutcomes measure: Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab, secondaryOutcomes measure: Time to definitive deterioration (TDD) for participants with IHC 3+ tumors in patient-reported Physical Functioning (PF) domain score as measured by the EORTC QLQ-C30, secondaryOutcomes measure: TDD for all participants in patient-reported PF domain score as measured by the EORTC QLQ-C30, secondaryOutcomes measure: TDD for participants with IHC 3+ tumors in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain and Pruritis), secondaryOutcomes measure: TDD for all participants in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rocky Mountain Cancer Centers, LLP, status: RECRUITING, city: Lone Tree, state: Colorado, zip: 80124, country: United States, geoPoint lat: 39.55171, lon: -104.8863, locations facility: Norton Cancer Institute - Audubon, status: NOT_YET_RECRUITING, city: Louisville, state: Kentucky, zip: 40217, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Minnesota Oncology Hematology, P.A., status: RECRUITING, city: Maple Grove, state: Minnesota, zip: 55369, country: United States, geoPoint lat: 45.07246, lon: -93.45579, locations facility: SCRI Oncology Partners, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Texas Oncology - DFW, status: RECRUITING, city: Dallas, state: Texas, zip: 75246, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Hospital Oncologico, Puerto Rico Medical Center, status: RECRUITING, city: Rio Piedras, zip: 00935, country: Puerto Rico, geoPoint lat: 18.39745, lon: -66.04989, hasResults: False