Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMI… (NCT06109779) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
United States, Australia, Belgium757 participantsStarted 2023-12-04
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing rilvegostomig combined with chemotherapy as adjuvant therapy after surgery for biliary tract cancer — can you explain what rilvegostomig is and why combining it with chemotherapy might help prevent the cancer from coming back compared to chemotherapy alone?
2Since this is a Phase 3 trial, what do we know so far about the safety profile of rilvegostomig, and are there any side effects specific to this combination that I should be aware of and watching for?
3The trial is no longer actively recruiting new patients — does that mean it's still worth exploring whether I might be eligible to join, or should we focus on other options?
4The main thing this trial is measuring is recurrence-free survival after surgical resection — based on my specific surgery results and pathology, would I even be a candidate for adjuvant therapy like this, and how does this trial's approach compare to the current standard of care?
5What are the practical demands of being in a trial like this — how often would I need to come in for treatment and monitoring — and how does that weigh against pursuing standard adjuvant treatment outside of a trial setting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence free survival (RFS) for Arm A vs. Arm B