Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Bile Duct Cancer
Gallbladder Cancer
18 Years and older, Male and Female
D7025C00001 (primary)
NCI-2024-04612
2023-506054-20-00
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.
Objectives
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
- 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
Treatment Sites in Georgia
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