Active not recruitingPHASE3INTERVENTIONAL

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

This study is investigating a new treatment called nivolumab for a type of liver cancer called hepatocellular carcinoma (HCC). It's designed for people who have already had their liver cancer successfully removed, either by surgery or a local treatment like ablation. Doctors believe these people are at a higher risk of their cancer returning. The main goal is to find out if nivolumab can help prevent the cancer from coming back (this is called 'recurrence-free survival') compared to a 'placebo' (which looks like the study drug but contains no active medicine). This type of study is important for finding better ways to keep cancer from returning after initial treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

545

Start

18 Apr 2018

Estimated completion

27 Feb 2031

Hepatocellular Carcinoma Liver Cancer

What is this study about?

This clinical trial is called a 'Phase 3' study. This means it's one of the final steps in proving if a new treatment is safe and effective before it can potentially be made widely available. We're looking at a medicine called nivolumab to see if it can help people who have already been treated for a type of liver cancer called hepatocellular carcinoma (HCC). HCC is the most common type of liver cancer in adults.

The study focuses on people who have had their liver cancer successfully removed, either through an operation (resection) or a procedure called ablation, which uses heat or cold to destroy cancer cells. Even after successful treatment, there's a chance the cancer can come back, especially for certain individuals who are considered to be at high risk. This study aims to find out if nivolumab can lower that risk and stop the cancer from returning. Some people in the study will receive nivolumab, while others will receive a placebo – a dummy treatment that looks like nivolumab but doesn't contain any active medicine. This allows researchers to fairly compare the effects of nivolumab.

Finding ways to prevent liver cancer from returning after initial treatment is very important. If nivolumab proves to be effective, it could offer a new option for patients at risk of recurrence, potentially improving their long-term health and quality of life. The study will carefully monitor participants to see how well nivolumab works and if it has any side effects.

Key takeaways

This study is for people who have had liver cancer (HCC) successfully treated.
It aims to see if nivolumab can stop the cancer from returning.
Participants will receive either nivolumab or a placebo.
The study involves regular visits, tests, and medical monitoring.
It's a 'Phase 3' study, meaning it's a key step in evaluating a new treatment.

Who may be eligible?

To join this study, you would first need to have been diagnosed with hepatocellular carcinoma (HCC), a type of liver cancer. You must have already had your cancer successfully removed, either by surgery or a treatment called ablation. The study includes people with HCC regardless of whether it's related to a virus (like hepatitis B or C) or not.

There are also some health checks. Your liver function needs to be good (doctors use a score called Child-Pugh 5 or 6). Also, you need to be generally well and able to carry out your normal daily activities, with an ECOG performance status of 0 or 1. You cannot have received any prior treatment for your liver cancer, including localised treatments, and must not have received a liver transplant or be on a waiting list for one.

You wouldn't be able to join if your cancer is a rare type called fibrolamellar HCC, sarcomatoid HCC, or if you have a mix of liver cancer and bile duct cancer. People with any other cancer in their body or cancer that has spread would also not be able to take part. Finally, if you've had certain live vaccines in the last 30 days, you would need to wait.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been diagnosed with hepatocellular carcinoma (HCC).
My liver cancer has been completely removed by surgery or ablation.
My doctors think I am at high risk of the cancer coming back.
My liver function is generally good (Child-Pugh 5 or 6).
I am generally well and able to do my normal daily activities.
I have not had any previous treatments for my liver cancer.

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either the study drug, nivolumab, or a placebo (an inactive substance that looks like the study drug). You and your doctors won't know which one you're receiving. Both nivolumab and the placebo will likely be given through a vein (intravenously).

You will have regular appointments at the hospital for blood tests, physical examinations, and scans to check your health and see if the cancer has returned. The exact number of visits and the types of tests will be clearly explained by the study team. You will be monitored closely for any side effects and to see how well the treatment is working. The total duration of your participation in the study, including the treatment period and follow-up, will be several years, as researchers need to track participants for some time to see the long-term effects on cancer recurrence.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as receiving a new treatment like nivolumab that could help prevent your liver cancer from returning. You'll also receive very close medical monitoring. However, there are potential risks, as nivolumab is a powerful medicine and could have side effects, which the study team will discuss in detail with you. The placebo treatment has no active drug, so it won't directly treat your cancer or prevent its return. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (184)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 0081
Verified postcode
Anniston, United States
Mayo Clinic in Arizona - Phoenix
Verified postcode
Phoenix, United States
Arizona Oncology Associates, PC - HOPE
Verified postcode
Tucson, United States
Local Institution - 0135
Verified postcode
Los Angeles, United States
Local Institution - 0088
Verified postcode
Palo Alto, United States
Local Institution - 0085
Verified postcode
San Francisco, United States
Local Institution - 0235
Verified postcode
Aurora, United States
Local Institution - 0267
Verified postcode
Miami, United States
Sylvester Comprehensive Cancer Center/ UMHC
Verified postcode
Miami, United States
Local Institution - 0163
Verified postcode
Tampa, United States
Local Institution - 0009
Verified postcode
Atlanta, United States
Local Institution - 0025
Verified postcode
Westwood, United States

Common questions

What is hepatocellular carcinoma (HCC)?

HCC is the most common type of primary liver cancer that starts in the liver.

What is nivolumab?

Nivolumab is a type of immunotherapy drug that helps your own immune system fight cancer.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the study drug but contains no active medicine, used for comparison.

What does 'recurrence-free survival' mean?

It means the length of time a person lives without their cancer coming back after treatment.

Will I know if I'm getting nivolumab or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctor will know which treatment you are receiving until the study is over, unless there's a medical need to find out.