All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

This research study is looking at a new combination treatment for a type of advanced liver cancer called hepatocellular carcinoma. The drugs being tested are nivolumab and ipilimumab, given together. The main goal is to see if this new combination helps people live longer compared to the usual treatments, sorafenib or lenvatinib. This study is for people who have advanced liver cancer and haven't had any treatment for it before. It's a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available. Doctors involved will be monitoring participants closely to understand how safe and effective the new treatment is.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Bristol-Myers Squibb
Enrolment target
732
Start
30 Sep 2019
Estimated completion
09 Jul 2026

What is this study about?

This study is an important step in finding better ways to treat advanced hepatocellular carcinoma, which is a common type of liver cancer. Researchers want to find out if combining two new treatments, nivolumab and ipilimumab, works better than the standard treatments currently used, which are sorafenib or lenvatinib.

Liver cancer can be a challenging condition, and doctors are always looking for new medicines that can improve how long people live and their quality of life. By comparing these different approaches, the study aims to identify if the nivolumab and ipilimumab combination offers a significant advantage for patients who haven't yet received treatment for their advanced liver cancer.

Taking part in a study like this helps advance medical knowledge and could lead to new treatments becoming available for many more people in the future. It's about carefully testing new options to make sure they are safe and effective.

Key takeaways

  • This study is comparing a new drug combination for advanced liver cancer.
  • It's for people who haven't had previous treatment for advanced liver cancer.
  • The goal is to see if the new treatment helps people live longer.
  • You'll have regular hospital visits and monitoring if you join.
  • You can leave the study at any time if you change your mind.

Who may be eligible?

To join this study, you must have a confirmed diagnosis of advanced liver cancer (hepatocellular carcinoma) and your doctors must be able to measure your cancer to track how it responds to treatment. You also can't have received any previous medication for your advanced liver cancer.

Your liver health must be generally good, as measured by a score called Child-Pugh 5 or 6, and your general health and how well you can go about your daily activities should be quite good (known as an ECOG performance status of 0 or 1).

However, there are certain reasons why you might not be able to join. For example, if you have a specific rare type of liver cancer (like fibrolamellar HCC), have had a liver transplant, or have experienced severe confusion due to liver problems in the last year. Also, if your cancer has spread to your brain or the lining around it, you wouldn't be able to participate.

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.

  1. Do I have a confirmed diagnosis of advanced liver cancer?
  2. Have I received any treatment for my advanced liver cancer already?
  3. Is my general health and liver function reasonably good?
  4. Do I have any other serious health conditions like brain metastases or a history of liver transplant?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be assigned to receive either the combination of nivolumab and ipilimumab or one of the standard treatments (sorafenib or lenvatinib). You won't get to choose which treatment you receive. You'll have regular visits to the hospital or clinic for blood tests, physical exams, and scans to check on your health and how the treatment is working. Doctors and nurses will explain when and how often you'll need to take the medication, which could be in the form of injections or pills.

Throughout the study, your health will be carefully monitored, and any side effects you experience will be recorded. The exact number of visits, tests, and the total length of time you'll be in the study will be explained in detail by the study team. This generally involves a period of active treatment followed by follow-up appointments.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new, experimental treatment that could be more effective than current standard options for your advanced liver cancer. However, as with all medical treatments, there are potential risks and side effects from the study drugs that will be fully explained to you. These can range from mild to more serious, and the study team will monitor you closely for them. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (210)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Local Institution - 0292
    Verified postcode
    Tucson, United States
  • Local Institution - 0288
    Verified postcode
    Coronado, United States
  • Local Institution - 0157
    Verified postcode
    Duarte, United States
  • Local Institution - 0077
    Verified postcode
    Washington D.C., United States
  • Local Institution - 0027
    Verified postcode
    Louisville, United States
  • Local Institution - 0190
    Verified postcode
    Baltimore, United States
  • Local Institution
    Verified postcode
    Ann Arbor, United States
  • Local Institution - 0018
    Verified postcode
    Detroit, United States
  • Local Institution - 0295
    Verified postcode
    Newark, United States
  • Local Institution - 0043
    Verified postcode
    Toledo, United States
  • Local Institution - 0284
    Verified postcode
    Pittsburgh, United States
  • Local Institution - 0304
    Verified postcode
    Dallas, United States

Common questions

What is advanced hepatocellular carcinoma?

It's a type of liver cancer that has grown or spread beyond its original site in the liver.

What does 'standard of care' mean?

It refers to the usual, widely accepted treatments that doctors currently use for a particular condition.

Will I know which treatment I'm getting?

In this type of study, participants are usually assigned to a treatment group by chance, and you may not know which specific treatment you are receiving.

Can I stop participating in the study if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

What is a 'Phase 3' study?

Phase 3 is an advanced stage of testing where a new treatment is compared against existing treatments to confirm its safety and effectiveness on a larger scale.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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