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Study of Nivolumab for Patients with Liver Cancer at High Risk of Recurrence After Surgery or Ablation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of liver cancer known as Hepatocellular Carcinoma (HCC). The study is investigating the effects of a treatment called Nivolumab, which is also known by its code name BMS-936558. Nivolumab is a medication that is given through an infusion, which means it is delivered directly into the bloodstream through a vein. The trial is comparing Nivolumab to a placebo to see how well it works in preventing the return of cancer in patients who have had surgery or other treatments to remove or destroy their liver tumors.

The purpose of the study is to see if Nivolumab can help patients with HCC who are at high risk of their cancer coming back after they have had surgery or a procedure to remove or destroy the cancer. Participants in the study will receive either Nivolumab or a placebo. The study will monitor the participants over time to see if the cancer returns and to assess their overall health and survival.

Participants will be randomly assigned to receive either the Nivolumab treatment or a placebo. The study will follow them for a period to observe the effects of the treatment. The main goal is to determine if Nivolumab can help keep the cancer from returning and to understand its impact on the participants' survival. This study is part of a larger effort to find better treatments for liver cancer and improve outcomes for patients at high risk of recurrence.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to one of two groups: one receiving the medication nivolumab and the other receiving a placebo. This process is double-blind, meaning neither the participants nor the researchers know which group each participant is in.

  2. Step 2

    Treatment administration

    Participants in the treatment group receive nivolumab, which is a medication administered through an intravenous infusion. The dosage is 10 mg/mL, and it is given as a solution for infusion.

    The placebo group receives an infusion that does not contain the active medication. Both groups receive their respective infusions at regular intervals as determined by the study protocol.

  3. Step 3

    Monitoring and follow-up

    Participants undergo regular monitoring to assess their health status and the effects of the treatment. This includes imaging studies to confirm disease-free status and to monitor for any recurrence of hepatocellular carcinoma.

    The primary goal is to evaluate recurrence-free survival, which is the time from randomization to the first documented disease recurrence or death from any cause.

  4. Step 4

    Study completion

    The study is estimated to conclude by December 16, 2025. At the end of the study, data from all participants will be analyzed to determine the effectiveness of nivolumab in preventing the recurrence of hepatocellular carcinoma compared to the placebo.

Who can join the trial?

9 criteria

  • Participants must be males or females who are 18 years old or older.
  • Participants should have a first diagnosis of **Hepatocellular Carcinoma (HCC)**, which is a type of liver cancer, that can be treated with surgery or local treatment aimed at curing the disease.
  • Participants can join if their HCC is not related to viruses, or if it is related to **Hepatitis B Virus (HBV)** or **Hepatitis C Virus (HCV)**.
  • Participants must have had either:
    • **Hepatic resection**, which is a surgery to remove part of the liver, with specific tumor characteristics: up to three tumors with at least one larger than 5 cm, or none larger than 5 cm but with certain aggressive features; or more than three tumors, none larger than 5 cm.
    • **Local ablation**, which is a treatment that destroys cancer cells using heat, with specific tumor characteristics: a single tumor larger than 3 cm but no more than 5 cm, or multiple tumors (up to 4), none larger than 5 cm.
    • Participants must have a complete response to resection, meaning the tumor was fully removed, or must have proof of complete removal after local ablation.
    • Participants need to have imaging tests showing no signs of the disease at least 4 weeks after complete tumor removal and within 4 weeks before starting the trial.
    • Participants must have a **Child-Pugh Score** of 5 or 6, which is a system used to assess liver function.
    • Participants must have an **Eastern Cooperative Oncology Group (ECOG) performance status** of 0 or 1, which measures how well they can perform daily activities.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer besides Hepatocellular Carcinoma cannot participate. Hepatocellular Carcinoma is a type of liver cancer.
  • Patients who have had a recurrence of their cancer after treatment are not eligible.
  • Patients who are currently receiving treatment with other experimental drugs cannot join the study.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of severe allergic reactions to similar drugs are not eligible.
  • Patients who have participated in another clinical trial within the last 30 days are excluded.
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Investigated drugs

Nivolumab is a medication used in this clinical trial to help prevent the return of liver cancer after surgery or other treatments. It works by helping the immune system recognize and attack cancer cells more effectively. This trial is testing whether nivolumab can improve the chances of staying cancer-free compared to not using it.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in preventing the recurrence of hepatocellular carcinoma, a type of liver cancer, after surgical removal or ablation. Nivolumab works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Hepatocellular Carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis infection. The disease may initially present with symptoms like abdominal pain, weight loss, or jaundice. As it progresses, the tumor can grow and spread to other parts of the liver or beyond. The progression of the disease can lead to liver dysfunction and complications related to tumor growth. Early stages might not show significant symptoms, making regular monitoring important for those at risk.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508726-10-00Protocol codeCA209-9DXEstimated enrolment796 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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