drugset / Trial / NCT06109779

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

NCT06109779

Phase 3 Active not recruiting 760 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-12-04
Primary completion
2029-01-02
Completion
2030-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilvegostomig Other / unclassified Intravenous
Background Capecitabine Small molecule 1250 mg/m2 Oral
Background Cisplatin Other / unclassified 25 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background S-1 Small molecule 40 mg Oral
Background S-1 Small molecule 50 mg Oral
Background S-1 Small molecule 60 mg Oral

Indications