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Biliary Tract CancerCancerDrugPhase 3

What this study is

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.

What's being tested

  • Zanidatamab

    Intervention · DRUG

  • Cisplatin

    Intervention · DRUG

  • Gemcitabine

    Intervention · DRUG

  • Pembrolizumab

    Intervention · DRUG

  • Durvalumab

    Intervention · DRUG

All interventions

Administered intravenously (IV)

Study details

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
Sponsor
Jazz Pharmaceuticals
Conditions
Biliary Tract Cancer
Enrolling
286 people
Starts
2024-07-19
Est. completion
2030-04-01
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗