Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer after Resection (ARTEMIDE-Biliary01)
Study identifier:D7025C00001
ClinicalTrials.gov identifier:NCT06109779
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
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)
Medical condition
biliary tract cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Rilvegostomig, Placebo, Capecitabine, Gemcitabine/Cisplatin, S-1 [Tegafur/Oteracil/gimeracil]
Sex
All
Estimated Enrollment
750
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 04 Dec 2023
Estimated Primary Completion Date: 29 Jun 2029
Estimated Study Completion Date: 30 Sept 2030
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| 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 |
