Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

• Status: Recruiting
• Trial end date: 2030-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Capecitabine; Gemcitabine; Tegafur

Criteria

Inclusion 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

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.