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A trial to learn if rilvegostomig with chemotherapy given after surgery is safe in people with biliary tract cancer and works to delay when the cancer comes back after surgery
EU CTIS ID: 2023-506054-20-00
What this study is testing
The primary objective is to demonstrate superiority of rilvegostomig + chemotherapy relative to placebo + chemotherapy by assessment of RFS in participants with BTC after resection with curative intent
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) 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
You likely can't join if
- 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
See the full eligibility criteria
- Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- China
- United States
- Japan
- India
- Hong Kong
- United Kingdom
- Australia
- Canada
- Taiwan
- Thailand
- Turkey
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; China; United States; Japan; India; Hong Kong and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.