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Taking people in United KingdomPhase 3

Tests rilvegostomig or durvalumab with chemotherapy for advanced biliary tract cancer

Compares rilvegostomig with chemotherapy against durvalumab with chemotherapy in adults with advanced biliary tract cancer.

Key facts

Who runs it
AstraZeneca
Where
Birmingham, Glasgow, Greater London, Leeds, London, and Manchester, United KingdomSee the 6 sitesAlso in 18 other countries, 159 sites
Registry title
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
Status
Recruiting
Phase
Phase 3
People taking part
1,100 people, planned
Started
4 Dec 2025
Expected to end
31 Jul 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Rilvegostomig
  • Durvalumab
  • Gemcitabine/Cisplatin
Record updated
28 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced biliary tract cancer who have not yet had treatment for the advanced disease. It compares rilvegostomig with durvalumab, each given with gemcitabine plus cisplatin.

Age
18 years or older
Sex
Men and women can join
Disease stage
Adenocarcinoma of the biliary tract (inside or outside the liver, or gallbladder) that cannot be removed by surgery, locally advanced or spread. Disease must be measurable on CT or MRI.
Earlier treatment
No earlier systemic treatment for advanced biliary tract cancer. No earlier treatment aimed at immune-regulating receptors or mechanisms.
Biomarker or test result
PD-L1 status must be known, tested at a central laboratory on a tumor sample.

Main reasons for not taking part

  • Ampullary carcinoma
  • Any earlier systemic therapy for unresectable, advanced or spread biliary tract cancer
  • Autoimmune or inflammatory disease needing long-term steroids or other immune-suppressing treatment
  • Current or past interstitial lung disease or pneumonitis of any grade
  • Other cancer treatment at the same time, besides the trial treatments

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC)
  • Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting
  • Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample
  • Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements
  • ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS > 1) over the previous 2 weeks prior to baseline at screening and prior to randomization
  • Adequate bone marrow and organ function

Who cannot take part

  • Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC
  • Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms
  • Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study
  • Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment
  • Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment
  • Ampullary carcinoma

Where in United Kingdom

Also in 18 other countries, 159 sites

  • BirminghamHospital not named in the registryTaking people
  • GlasgowHospital not named in the registryNot yet recruiting
  • Greater LondonHospital not named in the registryTaking people
  • LeedsHospital not named in the registryTaking people
  • LondonHospital not named in the registryTaking people
  • ManchesterHospital not named in the registryTaking people

About the trial

What the trial wants to find out

The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.

The 2 groups in the trial

  • Control ArmExisting treatment, for comparison

    Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

    Treatment: Durvalumab and Gemcitabine/Cisplatin

  • Experimental ArmTreatment being tested

    Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

    Treatment: Rilvegostomig and Gemcitabine/Cisplatin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)
Plain-language title
Tests rilvegostomig or durvalumab with chemotherapy for advanced biliary tract cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 September 2026