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)
AstraZeneca
1,100 participants
Dec 4, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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.
Interventions
Rilvegostomig IV (intravenous) Q3W
Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.
Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle
Locations(168)
View Full Details on ClinicalTrials.gov
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NCT07221253