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NCT06109779 · ClinicalTrials.gov record · last posted 2026-07-10

Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

StatusActive, Not Recruiting
PhasePhase 3
Started2023-12-04
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from the ClinicalTrials.gov record
A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.

Amendment record 22 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 22 times since 2023-10-26; most recent amendment 2026-07-09. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2026-03-03
Status change RecruitingActive, Not Recruitingv21
2023-12-15
Status change Not Yet RecruitingRecruitingv1
Trial Details
NCT Number NCT06109779
Lead Sponsor AstraZeneca
Conditions Biliary Tract Cancer
Enrollment 760 participants
Start Date 2023-12-04
Primary Completion 2029-01-02 (estimated)
Study Completion 2030-05-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-10