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