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
- Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1)
- Provision of a tumor sample collected at surgical resection.
- Randomization within 12 weeks after resection with adequate healing and removal of drains.
- Confirmed to be disease-free by imaging within 28 days prior to randomization.
- Eastern Cooperative Oncology Group performance status of 0 or 1
Exclusion criteria
- Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
- Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
- Any anti-cancer therapy for BTC prior to surgery
- Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
- Current or prior use of immunosuppressive medication within 14 days before the first dose
- Thromboembolic event within 3 months
- Active HBV or HCV infection unless treated.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06109779
Intervention or treatment
DRUG: Rilvegostomig
DRUG: Placebo
DRUG: Capecitabine
DRUG: Gemcitabine/Cisplatin
DRUG: S-1 [Tegafur/Oteracil/gimeracil]
Conditions
- Biliary Tract Cancer
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Research Site
Select from list below to view details:
Research Site
Camperdown, Australia
Research Site
Clayton, Australia
Research Site
Murdoch, Australia
Research Site
Reservoir, Australia
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Who is running the clinical trial?
AstraZeneca
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, Drug: Capecitabine, Drug: Gemcitabine/Cisplatin, Drug: S-1 [Tegafur/Oteracil/gimeracil] |
PLACEBO_COMPARATOR: Arm B
| Drug: Placebo, Drug: Capecitabine, Drug: Gemcitabine/Cisplatin, Drug: S-1 [Tegafur/Oteracil/gimeracil] |
What is the study measuring?
Primary Outcome
| Measure | Description | 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
| Measure | Description | 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 |
References
Clinical Trials Gov: Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)Other trials to consider
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