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Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-12-04
Primary completion: 2029-06-29
Study completion finish: 2030-09-30
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06109779
Intervention or treatment
DRUG: Rilvegostomig
DRUG: Placebo
DRUG: Capecitabine
DRUG: Gemcitabine/Cisplatin
DRUG: S-1 [Tegafur/Oteracil/gimeracil]
Conditions
- • Biliary Tract Cancer
Find a site
Closest Location:
Research Site
Research sites nearby
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Research Site
Camperdown, Not Specified, Australia
Research Site
Clayton, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Arm A
| DRUG: Rilvegostomig
|
PLACEBO_COMPARATOR: Arm B
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Recurrence free survival (RFS) for Arm A vs. Arm B | 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. | Approximately 5 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Overall Survival (OS) for Arm A vs. Arm B | Overall survival is defined as the time from randomization until the date of death due to any cause. | up to 7 years |
Frequently Asked Questions
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