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
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugRilvegostomig
Rilvegostomig IV (intravenous) Q3W
- DrugDurvalumab
Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.
- DrugGemcitabine/Cisplatin
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)
- Research SiteBirmingham, Alabama
- Research SitePhoenix, Arizona
- Research SiteTucson, Arizona
- Research SiteDuarte, California
- Research SiteOrange, California
- Research SiteSanta Monica, California