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

Summary

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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Zanidatamab

  Administered intravenously (IV)

• Drug
  Cisplatin

  Administered intravenously (IV)

• Drug
  Gemcitabine

  Administered intravenously (IV)

• Drug
  Pembrolizumab

  Administered intravenously (IV)

• Drug
  Durvalumab

  Administered intravenously (IV)

Locations (184)