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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07221253
Phase
PHASE3
Status
Recruiting
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Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rilvegostomig — DRUG
    Rilvegostomig IV (intravenous) Q3W
  • Durvalumab — DRUG
    Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.
  • Gemcitabine/Cisplatin — DRUG
    Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

Study Details

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.

Key Dates

Start date
Dec 4, 2025
Status verified
Mar 2026
Primary completion
Jul 4, 2029
Completion
Jul 4, 2029

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Arm
    Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)
  • Experimental: Experimental Arm
    Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

Primary Outcome Measure

Overall Survival (OS) in the PDL1 ≥ 1% population [ Time Frame: approximately 4 years ]

Central Contacts

Locations (33)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SitePhoenixArizona85054-
Research SiteTucsonArizona85719-
Research SiteDuarteCalifornia91010-
Research SiteOrangeCalifornia92868-
Research SiteSanta MonicaCalifornia90404-
Research SiteStanfordCalifornia94305-5847-
Research SiteAuroraColorado80045-
Research SiteHartfordConnecticut06102-
Research SiteNew HavenConnecticut06510-
Research SiteWashington D.C.District of Columbia20007-
Research SiteWashington D.C.District of Columbia20037-
Research SiteJacksonvilleFlorida32209-
Research SiteJacksonvilleFlorida32224-
Research SiteMariettaGeorgia30060-
Research SiteChicagoIllinois60612-
Research SiteChicagoIllinois60637-
Research SiteLouisvilleKentucky40207-
Research SiteBaltimoreMaryland21205-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48202-
Research SiteRochesterMinnesota55905-
Research SiteOmahaNebraska68198-5885-
Research SiteSanta FeNew Mexico87505-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10032-
Research SiteNew YorkNew York10065-
Research SitePortlandOregon97239-
Research SitePhiladelphiaPennsylvania19104-
Research SitePhiladelphiaPennsylvania19111-
Research SitePittsburghPennsylvania15212-
Research SiteProvidenceRhode Island02903-
Research SiteSioux FallsSouth Dakota57105-

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