NCT07221253From ClinicalTrials.govRecruiting

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

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)

Biliary Tract Cancer

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: AstraZeneca
Enrolment target: 1,100
Started: 4 December 2025
Main results due: 31 July 2029
Study sites: 183
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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, or psoriasis) requiring systemic treatment.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(183)

Research Site
Birmingham, Alabama, United States
Recruiting
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Phoenix, Arizona, United States
Recruiting
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Tucson, Arizona, United States
Recruiting
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Duarte, California, United States
Recruiting
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Los Angeles, California, United States
Recruiting
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Orange, California, United States
Recruiting
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Palo Alto, California, United States
Recruiting
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Aurora, Colorado, United States
Recruiting
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Hartford, Connecticut, United States
Recruiting
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New Haven, Connecticut, United States
Recruiting
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Washington D.C., District of Columbia, United States
Recruiting
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Washington D.C., District of Columbia, United States
Not yet recruiting
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Gainesville, Florida, United States
Recruiting
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Jacksonville, Florida, United States
Recruiting
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Miami, Florida, United States
Not yet recruiting
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Marietta, Georgia, United States
Recruiting
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Chicago, Illinois, United States
Not yet recruiting
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Chicago, Illinois, United States
Recruiting
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Indianapolis, Indiana, United States
Not yet recruiting
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Louisville, Kentucky, United States
Recruiting
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Louisville, Kentucky, United States
Withdrawn
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Baltimore, Maryland, United States
Recruiting
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Ann Arbor, Michigan, United States
Not yet recruiting
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Detroit, Michigan, United States
Not yet recruiting
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Rochester, Minnesota, United States
Recruiting
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Omaha, Nebraska, United States
Not yet recruiting
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Santa Fe, New Mexico, United States
Recruiting
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Mineola, New York, United States
Recruiting
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New York, New York, United States
Recruiting
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New York, New York, United States
Recruiting
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New York, New York, United States
Withdrawn
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Oklahoma City, Oklahoma, United States
Not yet recruiting
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Portland, Oregon, United States
Not yet recruiting
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Lancaster, Pennsylvania, United States
Recruiting
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Philadelphia, Pennsylvania, United States
Recruiting
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Pittsburgh, Pennsylvania, United States
Recruiting
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Providence, Rhode Island, United States
Recruiting
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Pierre, South Dakota, United States
Recruiting
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Sioux Falls, South Dakota, United States
Recruiting
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Nashville, Tennessee, United States
Not yet recruiting
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Houston, Texas, United States
Not yet recruiting
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Seattle, Washington, United States
Not yet recruiting
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Clayton, Australia
Recruiting
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Darlinghurst, Australia
Recruiting
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Gosford, Australia
Recruiting
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Murdoch, Australia
Recruiting
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South Brisbane, Australia
Not yet recruiting
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Anderlecht, Belgium
Recruiting
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Edegem, Belgium
Recruiting
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Leuven, Belgium
Recruiting
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Liège, Belgium
Recruiting
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Roeselare, Belgium
Recruiting
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Barretos, Brazil
Recruiting
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Natal, Brazil
Recruiting
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Porto Alegre, Brazil
Recruiting
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Ribeirão Preto, Brazil
Recruiting
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São Paulo, Brazil
Recruiting
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Vitória, Brazil
Recruiting
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Calgary, Alberta, Canada
Recruiting
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Vancouver, British Columbia, Canada
Not yet recruiting

Showing 60 of 183 sites — filter to narrow it down. 153 of the 183 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07221253. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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