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

Phase 3

Recruiting

• Conditions: Biliary Tract Cancer
• Interventions: Drug: Rilvegostomig; Drug: Placebo; Drug: Capecitabine; Drug: Gemcitabine/Cisplatin; Drug: S-1 [Tegafur/Oteracil/gimeracil]

• Registration Number: NCT06109779
• Lead Sponsor: AstraZeneca

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 with curative intent.

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 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.

Study Timeline

• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-10-31
• Study Start: 2023-12-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2029-06-29
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Rilvegostomig	Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Arm A	Gemcitabine/Cisplatin	Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Arm B	Placebo	Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Arm B	Gemcitabine/Cisplatin	Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Arm B	S-1 [Tegafur/Oteracil/gimeracil]	Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Arm A	S-1 [Tegafur/Oteracil/gimeracil]	Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Arm A	Capecitabine	Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Arm B	Capecitabine	Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)

Primary Outcome Measures

Name	Time	Method
Recurrence free survival (RFS) for Arm A vs. Arm B	Approximately 5 years	Recurrence-free survival (RFS) is defined as the time from randomization until the date of radiological recurrence guided by RECIST 1.1 or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS) for Arm A vs. Arm B	up to 7 years	Overall survival is defined as the time from randomization until the date of death due to any cause.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sutton, United Kingdom