RecruitingPhase 3

A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)

United States, Australia, Belgium1,100 participantsStarted 2025-12-04

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key inclusion Criteria: * 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. Key exclusion Criteria: * Ampullary carcinoma * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 3 trial comparing rilvegostomig or durvalumab added to chemotherapy against standard chemotherapy alone for biliary tract cancer — how does the Phase 3 status affect what we already know about the safety and effectiveness of these combinations?
2The trial measures overall survival specifically in patients whose tumors have PDL1 expression of 1% or higher — would my tumor need to be tested for PDL1 levels to even be considered for this study, and do we already have that result?
3Since this trial is actively recruiting and involves being assigned to one of multiple treatment arms, how would we know which treatment I'd receive, and is there a chance I'd end up on a regimen that's less aggressive than what you'd recommend outside the trial?
4Durvalumab is already used in biliary tract cancer treatment — can you help me understand how participating in this trial compares to starting standard first-line treatment with durvalumab plus chemotherapy right now, and what I might gain or give up by waiting to enroll?
5Given that this is a first-line treatment trial, does joining it mean I'd need to delay any other treatment options you're already considering for me, and how would that affect my overall care plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Survival (OS) in the PDL1 ≥ 1% population

Timeframe: approximately 4 years

Trial details

NCT IDNCT07221253

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-07-31

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Biliary Tract Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.