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

Study acronym: AB02
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 177 → 183 locations Interventions: Durvalumab (Drug), Gemcitabine/Cisplatin (Drug), Rilvegostomig (Drug) to Durvalumab (Drug), Gemcitabine/Cisplatin (Drug), Rilvegostomig (Drug) · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 2 of 16 entries Show 3 more changesShow less
    • Interventions: Durvalumab (Drug), Gemcitabine/Cisplatin (Drug), Rilvegostomig (Drug) to Durvalumab (Drug), Gemcitabine/Cisplatin (Drug), Rilvegostomig (Drug)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 16 entries
  2. Trial sites expanded: 174 → 177 locationsv7
  3. Site details revised at 28 of 174 sitesv6
  4. Trial sites expanded: 168 → 174 locations Primary and study completion dates: Jul 4, 2029 to Jul 31, 2029v5 Show 1 more changeShow less
    • Primary and study completion dates: Jul 4, 2029 to Jul 31, 2029
  5. Study sites: 165 to 168v4
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  1. Study sites: 162 to 165v3
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 92 to 162 · Primary and study completion dates: Jul 31, 2029 to Jul 4, 2029 · Start date changed from estimate of Dec 31, 2025 to Dec 4, 2025v2 Show 3 more changesShow less
    • Study sites: 92 to 162
    • Primary and study completion dates: Jul 31, 2029 to Jul 4, 2029
    • Start date changed from estimate of Dec 31, 2025 to Dec 4, 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07221253
Lead Sponsor AstraZeneca
Conditions Biliary Tract Cancer
Enrollment 1,100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov