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 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria