Study identifier:D7025C00001
ClinicalTrials.gov identifier:NCT06109779
EudraCT identifier:N/A
CTIS identifier:2023-506054-20-00
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
biliary tract cancer
Phase 3
No
Rilvegostomig, Placebo, Capecitabine, Gemcitabine/Cisplatin, S-1 [Tegafur/Oteracil/gimeracil]
All
750
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2025 by AstraZeneca
AstraZeneca
-
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.
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with curative intent. This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent.
Location
Status
Location
Montreal, QC, Canada, H4A 3J1
Status
Recruiting
Location
Toronto, ON, Canada, M4N 3M5
Status
Recruiting
Location
Halifax, NS, Canada, B3H 2Y9
Status
Recruiting
Location
Vancouver, BC, Canada, VSZ 4E6
Status
Recruiting
Location
Ottawa, ON, Canada, K1H 8L6
Status
Recruiting
Location
Toronto, ON, Canada, M5G 2M9
Status
Recruiting
Location
Frankfurt, Germany, 60488
Status
Recruiting
Location
London, United Kingdom, NW3 2QG
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: Arm A Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1) | 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 |
Placebo Comparator: Arm B Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1) | Drug: Placebo Placebo 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 |
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