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NCT07221253 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Biliary Tract Cancer, sponsored by AstraZeneca.

Recruiting
Registry status
Phase 3
Development phase
1,100
Enrollment target
20
Study locations

NCT07221253: Recruiting Phase 3 study of Biliary Tract Cancer, sponsored by AstraZeneca.

NCT07221253 is a Phase 3 study of Biliary Tract Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 1,100 participants, above the 209-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (426% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07221253, a Phase 3 study of Biliary Tract Cancer, is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 3
Development phase
1,100 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Overall Survival is defined as time from randomization until the date of death due to any cause.

Conditions Studied

Biliary Tract Cancer

Interventions

  • DRUG Rilvegostomig
  • DRUG Durvalumab
  • DRUG Gemcitabine/Cisplatin

Study Locations (20)

California

  • Research Site - Duarte
  • Research Site - Orange
  • Research Site - Santa Monica
  • Research Site - Stanford

Arizona

  • Research Site - Phoenix
  • Research Site - Tucson

Connecticut

  • Research Site - Hartford
  • Research Site - New Haven

District of Columbia

  • Research Site - Washington D.C.
  • Research Site - Washington D.C.

Florida

  • Research Site - Jacksonville
  • Research Site - Jacksonville

Illinois

  • Research Site - Chicago
  • Research Site - Chicago

Alabama

  • Research Site - Birmingham

Colorado

  • Research Site - Aurora

Trial Details

FieldValue
Enrollment Target 1,100 participants
Start Date 2025-12-04
Est. Completion 2029-07-04
Phase Phase 3
AstraZeneca

1,285 total trials

What NCT07221253 shows while recruiting

NCT07221253 is an interventional study that assigns participants to a tested intervention. Its 1,100 participants enrollment target places it among the larger protocols in the corpus, above the 209-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (426% higher).

The record links to 1 condition, with Biliary Tract Cancer appearing as the primary indexed condition, and to 3 interventions - of which Rilvegostomig is the first listed.

NCT07221253 names 20 study sites across 12 states, led by California, Arizona, Connecticut.

Frequently Asked Questions

What is clinical trial NCT07221253 about?

NCT07221253 is a clinical study titled "A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)". 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.

What is the current status of trial NCT07221253?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,100 participants. The study started on 2025-12-04. Estimated completion is 2029-07-04.

What conditions does trial NCT07221253 study?

This clinical trial studies the following conditions: Biliary Tract Cancer.

What interventions are being tested in trial NCT07221253?

The interventions under investigation include: Rilvegostomig (DRUG), Durvalumab (DRUG), Gemcitabine/Cisplatin (DRUG).

Who is sponsoring clinical trial NCT07221253?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07221253 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. 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 NCT07221253's enrollment target sits among peer trials

1,100 2nd of 36 the highest 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

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More recruiting context for NCT07221253

Source: ClinicalTrials.gov NCT07221253, the US trial registry maintained by the National Library of Medicine. NCT07221253 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.