Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plusCisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed deathprotein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab orPembrolizumab, where approved under local regulations) as first line of treatment forparticipants with human epidermal growth factor receptor 2 (HER2)-positive biliary tractcancer.
Description for laymen
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plusCisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed deathprotein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab orPembrolizumab, where approved under local regulations) as first line of treatment forparticipants with human epidermal growth factor receptor 2 (HER2)-positive biliary tractcancer.
JSON Data
{
"short_title": "JZP598-302",
"data_mode": "900",
"data_mode_number": "000002394",
"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",
"accrual_state": "planned",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": "NCT06282575",
"eudract_number": null,
"general_contact_email": null,
"general_contact_phone": null,
"hauptpruefer_dd_name": "Prof. Dr. med. Gunnar Folprecht",
"description_laie_de": "Ziel dieser Studie ist es, die Wirksamkeit und Sicherheit von Zanidatamab plus CisGem (Cisplatin und Gemcitabin) mit oder ohne Zusatz eines Inhibitors des programmierten Todesproteins 1/Ligand-1 (PD-1/L1) (nach Wahl des Arztes entweder Durvalumab oder Pembrolizumab, sofern nach den lokalen Vorschriften zugelassen) als Erstlinienbehandlung f\u00fcr Teilnehmer mit humanem epidermalem Wachstumsfaktor-Rezeptor 2 (HER2)-positivem Gallengangskrebs zu untersuchen.",
"description_laie_en": "The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plusCisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed deathprotein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab orPembrolizumab, where approved under local regulations) as first line of treatment forparticipants with human epidermal growth factor receptor 2 (HER2)-positive biliary tractcancer.",
"description_expert_de": "Ziel dieser Studie ist es, die Wirksamkeit und Sicherheit von Zanidatamab plus CisGem (Cisplatin und Gemcitabin) mit oder ohne Zusatz eines Inhibitors des programmierten Todesproteins 1/Ligand-1 (PD-1/L1) (nach Wahl des Arztes entweder Durvalumab oder Pembrolizumab, sofern nach den lokalen Vorschriften zugelassen) als Erstlinienbehandlung f\u00fcr Teilnehmer mit humanem epidermalem Wachstumsfaktor-Rezeptor 2 (HER2)-positivem Gallengangskrebs zu untersuchen.",
"description_expert_en": "The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plusCisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed deathprotein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab orPembrolizumab, where approved under local regulations) as first line of treatment forparticipants with human epidermal growth factor receptor 2 (HER2)-positive biliary tractcancer.",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "III",
"main_cat_id": 2,
"sub_cat_id": 7
}
