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

Phase 3

Recruiting

• Conditions: Adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma or muscle invasive gallbladder cancer GBC)

• Registration Number: 2023-506054-20-00
• Lead Sponsor: Astrazeneca AB

Brief Summary

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

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: 2025-08
• Last Update Submitted: 2025-08-22
• Last Update Posted: 2025-08-24
• Primary Completion: 2029-01-02
• Study Completion: 2030-05-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Not specified
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence free survival (RFS) for Arm A vs. Arm B		Recurrence free survival (RFS) for Arm A vs. Arm B

Secondary Outcome Measures

Name	Time	Method
Patient-reported tolerability Arm A vs. Arm B		Patient-reported tolerability Arm A vs. Arm B
Progression Free Survival (PFS) following recurrence Arm A vs. Arm B		Progression Free Survival (PFS) following recurrence Arm A vs. Arm B
Overall Survival (OS) for Arm A vs. Arm B		Overall Survival (OS) for Arm A vs. Arm B

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sutton, United Kingdom