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A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for Biliary Tract Cancer

This study is looking at two different treatment combinations for advanced biliary tract cancer (cancer of the bile ducts or gallbladder) that has not been treated before. It compares rilvegostomig with gemcitabine and cisplatin to durvalumab with gemcitabine and cisplatin. Both rilvegostomig and durvalumab are immunotherapy drugs, meaning they help your body's immune system fight cancer. To join, you must have a confirmed diagnosis of biliary tract cancer that is advanced or has spread, and your tumor's PD-L1 status (a protein that can be found on cancer cells) must be known. The main goal is to see if one treatment helps people live longer, specifically in those with a certain level of PD-L1. The study is currently recruiting about 1100 participants.

Study design
This study is comparing two different drug combinations for advanced biliary tract cancer. It plans to enroll about 1100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for overall survival for approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07221253

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~1,100 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:RilvegostomigDurvalumabGemcitabine/Cisplatin

At a glance

Recruiting sites
140 of 177 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS) in the PDL1 ≥ 1% population
Measured over approximately 4 years

Conditions

Biliary Tract Cancer

Explore related trials

Extrahepatic CholangiocarcinomaGallbladder CarcinomaIntrahepatic CholangiocarcinomaMalignant neoplasm of biliary tract

Where it's being run

177 sites across 44 states
China22
Germany17
Japan12
South Korea9
India8
Taiwan8
Brazil6
Poland6

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
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Eligibility criteria

Inclusion

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.

Exclusion

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, or psoriasis) requiring systemic treatment.

What this trial measures

  • Overall Survival (OS) in the PDL1 ≥ 1% populationapproximately 4 years

    Overall Survival is defined as time from randomization until the date of death due to any cause.