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

NCT06109779 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 757

Last updated 2026-03-04

No results posted yet for this 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.

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

Placebo

Placebo IV (intravenous) Q3W

DRUG

Rilvegostomig

Rilvegostomig IV (intravenous) Q3W

DRUG

Capecitabine

Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice

DRUG

Gemcitabine/Cisplatin

Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

DRUG

S-1 [Tegafur/Oteracil/gimeracil]

S-1 \[Tegafur/Oteracil/gimeracil\] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2029-01-02
Completion
2030-05-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Japan
  • Norway
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06109779 on ClinicalTrials.gov