This study is in progress, not accepting new patients

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

a study on Biliary Tract Cancer Cholangiocarcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
study ends around
Principal Investigator
by Farshid Dayyani

Description

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.

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)

Details

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.

Keywords

Biliary Tract Cancer, Adenocarcinoma of the biliary tract, Gall bladder cancer, Intrahepatic Cholangiocarcinoma, Distal Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Klatskin Tumors, Bile duct cancer, Immunotherapy, Cholangiocarcinoma, Rilvegostomig, S-1, Gemcitabine/cisplatin, Capecitabine, Biliary Tract Neoplasms, Gallbladder Neoplasms, Klatskin Tumor, Bile Duct Neoplasms, Gemcitabine, Cisplatin, S 1 (combination), Tegafur, S-1 [Tegafur/Oteracil/gimeracil]

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • Research Site
    Orange California 92868 United States
  • Research Site
    Los Angeles California 90089 United States

Lead Scientist at UC Irvine

  • Farshid Dayyani
    Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 134 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT06109779
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 760 people participating
Last Updated