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AstraZeneca Clinical Study Information Center 1-877-240-9479
information.center@astrazeneca.com


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Be Part of Research - Trial Details - Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
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Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

Recruiting

Open to: ALL

Age: 18.0 - 99.0

Dundee Glasgow London Leeds Greater London Birmingham

Medical Conditions

Biliary Tract Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naĂŻve HER2-expressing BTC.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2024 Jun 2028

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Standard of care chemotherapy by intravenous infusion

Intervention Arm Group : Standard of Care;

Intervention Type : DRUG
Intervention Description : Standard of care chemotherapy by intravenous infusion

Intervention Arm Group : Standard of Care;

Intervention Type : DRUG
Intervention Description : Standard of care immunotherapy by intravenous infusion

Intervention Arm Group : Standard of Care;

Intervention Type : DRUG
Intervention Description : Experimental therapy by intravenous infusion

Intervention Arm Group : Trastuzumab deruxtecan;Trastuzumab deruxtecan + rilvegostomig;

Intervention Type : DRUG
Intervention Description : Experimental therapy by intravenous infusion

Intervention Arm Group : Trastuzumab deruxtecan + rilvegostomig;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : A semi-quantitative immunohistochemical assay to determine HER2 overexpression in FFPE breast cancer tissues routinely processed for histological evaluation.

Based on a primary monoclonal rabbit antibody which visualises Her2 overexpression utilising a fully automated IHC platform (Dako Omnis).

Intervention Arm Group : Standard of Care;Trastuzumab deruxtecan;Trastuzumab deruxtecan + rilvegostomig;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : A qualitative immunohistochemical assay to determine the level of PD-L1 expression in FFPE non-small cell lung cancer (NSCLC) tissues routinely processed for histological evaluation. Based on a rabbit monoclonal anti-PD-L1 clone SP263 which visualises PD-L1 protein using a VENTANA BenchMark ULTRA instrument

Intervention Arm Group : Standard of Care;Trastuzumab deruxtecan;Trastuzumab deruxtecan + rilvegostomig;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Research Site
    Dundee
    DD1 9SY
  • Research Site
    Glasgow
    G12 0YN
  • Research Site
    London
    EC1A 7BE
  • Research Site
    Leeds
    LS9 7TF
  • Research Site
    Greater London
    SW3 6JJ
  • Research Site
    Birmingham
    B15 2GW

AstraZeneca Clinical Study Information Center 1-877-240-9479
information.center@astrazeneca.com



The study is sponsored by AstraZeneca



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Read full details for Trial ID: NCT06467357
Last updated 29 April 2025

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