Status:
RECRUITING
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Lead Sponsor:
AstraZeneca
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 investigat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 3 2030
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06109779
Start Date
December 4 2023
End Date
May 3 2030
Last Update
November 26 2025
Active Locations (210)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Phoenix, Arizona, United States, 85054
3
Research Site
Duarte, California, United States, 91010
4
Research Site
Los Angeles, California, United States, 90089