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NCT06109779 · ClinicalTrials.gov registry record · Phase 3
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
A Phase 3 study of Biliary Tract Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 757
- Enrollment target
- 20
- Study locations
NCT06109779: Active Phase 3 study of Biliary Tract Cancer, sponsored by AstraZeneca.
NCT06109779 is a Phase 3 study of Biliary Tract Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 757 participants, above the 218-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (247% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06109779, a Phase 3 study of Biliary Tract Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 757 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Recurrence-free survival (RFS) is defined as the time from randomization until the date of radiological recurrence guided by RECIST 1.1 or death due to any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Capecitabine
- DRUG Rilvegostomig
- DRUG Gemcitabine/Cisplatin
- DRUG S-1 [Tegafur/Oteracil/gimeracil]
Study Locations (20)
California
- Research Site - Los Angeles
- Research Site - Orange
- Research Site - Stanford
Colorado
- Research Site - Aurora
- Research Site - Littleton
New York
- Research Site - Commack
- Research Site - Mineola
Alabama
- Research Site - Birmingham
Arizona
- Research Site - Phoenix
District of Columbia
- Research Site - Washington D.C.
Florida
- Research Site - Jacksonville
Georgia
- Research Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 757 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2030-05-03 |
| Phase | Phase 3 |
What the registry record for NCT06109779 still lists
NCT06109779 is an interventional study that assigns participants to a tested intervention. The registered 757 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (247% higher).
The record links to 1 condition, with Biliary Tract Cancer appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT06109779 names 20 study sites across 16 states, led by California, Colorado, New York.
Frequently Asked Questions
What is clinical trial NCT06109779 about?
NCT06109779 is a clinical study titled "Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)". 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.
What is the current status of trial NCT06109779?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 757 participants. The study started on 2023-12-04. Estimated completion is 2030-05-03.
What conditions does trial NCT06109779 study?
This clinical trial studies the following conditions: Biliary Tract Cancer.
What interventions are being tested in trial NCT06109779?
The interventions under investigation include: Placebo (DRUG), Capecitabine (DRUG), Rilvegostomig (DRUG), Gemcitabine/Cisplatin (DRUG), S-1 [Tegafur/Oteracil/gimeracil] (DRUG).
Who is sponsoring clinical trial NCT06109779?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06109779 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Biliary Tract Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06109779's enrollment target sits among peer trials
757 3rd of 36 higher than 34 of 36 other Biliary Tract Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Biliary Tract Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
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Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
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