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

Condition(s) studied

Investigational drug(s) / intervention(s)

Rilvegostomig: Rilvegostomig IV (intravenous) Q3W

Placebo: Placebo IV (intravenous) Q3W

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

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

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

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.

Eligibility

Primary outcome measure(s)

• Recurrence free survival (RFS) for Arm A vs. Arm B — Approximately 5 years
  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.

Trial sites (177)

+ 137 more sites — see the full list on the official registry below.