Study on Rilvegostomig and Chemotherapy as Additional Treatment for Biliary Tract Cancer After Surgery (ARTEMIDE-Biliary01)

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06109779

Provider View

This international clinical trial is testing the effectiveness and safety of the drug rilvegostomig, combined with chemotherapy, in patients who have had surgery to remove biliary tract cancer. The study aims to see if this combination can help prevent the cancer from coming back.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the drug rilvegostomig works when used with chemotherapy in patients who have had surgery to remove biliary tract cancer (BTC). The study will compare rilvegostomig to a placebo, alongside chemotherapy options chosen by the doctor, such as capecitabine, S-1, or gemcitabine/cisplatin. This research is focused on patients who are at risk of their cancer returning after surgery.

Description

This Phase III study is being conducted worldwide to test the effectiveness and safety of rilvegostomig, a new drug, in combination with chemotherapy for patients who have had surgery to remove biliary tract cancer (BTC). The study is randomized, meaning participants will be randomly assigned to receive either rilvegostomig or a placebo, along with chemotherapy chosen by their doctor. The chemotherapy options include capecitabine, S-1, or gemcitabine/cisplatin. The goal is to see if this combination can help prevent the cancer from coming back in patients who have had surgery with the intent to cure the cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with adenocarcinoma of the biliary tract, including intrahepatic or extrahepatic cholangiocarcinoma or muscle invasive gallbladder cancer, after complete surgical removal.
  • Able to provide a tumor sample from the surgery.
  • Can start the study within 12 weeks after surgery, with proper healing and no surgical drains.
  • Confirmed to be free of cancer by imaging tests within 28 days before starting the study.
  • In good general health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have cancer that is locally advanced, cannot be removed by surgery, or has spread to other parts of the body at the initial diagnosis.
  • Have ampullary cancer, neuroendocrine tumors, or mixed types of tumors.
  • Have received any anti-cancer treatment for BTC before surgery.
  • Have active or previously documented autoimmune or inflammatory disorders, or any severe or uncontrolled systemic disease.
  • Have used immunosuppressive medication within 14 days before the first dose of the study drug.
  • Have had a blood clotting event within the last 3 months.
  • Have active hepatitis B or C infection unless it has been treated.

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