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.
Plain-language title generated from the registry record
Registry title: A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
Key facts
- Where
- Chiba, Kashiwa, Kawasaki-shi, Kōtoku, Matsuyama, Nagoya, Osaka, Suita-shi, Takatsuki-shi, Ube, and Yokohama, JapanSee the 11 sites
- Phase
- Phase 3
Where in Japan
- ChibaChiba, JapanTaking people
- KashiwaKashiwa, JapanTaking people
- Kawasaki-shiKawasaki-shi, JapanTaking people
- KōtokuKōtoku, JapanTaking people
- MatsuyamaMatsuyama, JapanTaking people
- NagoyaNagoya, JapanTaking people
- OsakaOsaka, JapanTaking people
- Suita-shiSuita-shi, JapanTaking people
- Takatsuki-shiTakatsuki-shi, JapanTaking people
- UbeUbe, JapanTaking people
- YokohamaYokohama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07221253EU 2025-523085-24-00
- Record updated
- 28 September 2026
- Original description
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.Read full original descriptionShow less
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)
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.
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: 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.