What side effects are associated with this type of intervention?

The most common treatments for liver cancer include immune checkpoint inhibitors such as Nivolumab and Ipilimumab. These treatments can cause a range of side effects, primarily immune-related adverse events. Common side effects include fatigue, rash, diarrhea, and liver enzyme abnormalities. More severe but less frequent side effects can include colitis, hepatitis, endocrinopathies, and pneumonitis. These side effects result from the immune system attacking normal organs and tissues in the body.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of liver cancer. Notably, Nivolumab (Opdivo) and Pembrolizumab (Keytruda) have been approved for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Additionally, the combination of Atezolizumab (Tecentriq) and Bevacizumab (Avastin) has been approved for the first-line treatment of patients with unresectable or metastatic HCC. These approvals highlight the growing role of immune checkpoint inhibitors in the management of liver cancer, similar to the combination of Nivolumab and Ipilimumab being studied in clinical trials.

What other types of research exist?

Promising novel alternatives to Nivolumab plus Ipilimumab for liver cancer patients include combination therapies involving other ICIs such as Pembrolizumab (anti-PD-1) and Atezolizumab (anti-PD-L1) combined with Bevacizumab (anti-VEGF). These combinations have demonstrated encouraging outcomes in clinical trials, showing improved overall survival and manageable safety profiles. Additionally, ongoing research into combining ICIs with other treatment modalities like targeted therapies, radiofrequency ablation, and cytotoxic agents may offer new therapeutic options in 2024.

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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Liver Cancer (CheckMate 9DW Trial)

Phase 3

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have an advanced HCC

Participants must have a diagnosis of HCC based on histological confirmation

Must not have

Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a combination of two drugs, nivolumab and ipilimumab, which help the immune system fight cancer. It targets patients with advanced liver cancer who haven't received any previous whole-body treatments. The goal is to see if these drugs can help patients live longer compared to standard treatments. Nivolumab and ipilimumab have been used in combination to treat various advanced cancers, showing promising results but with higher side effects compared to using a single drug.

Who is the study for?

This trial is for adults with advanced liver cancer (HCC) who haven't had systemic therapy before. They need to have a certain level of physical fitness (ECOG 0 or 1), and their liver must be functioning fairly well (Child-Pugh score 5 or 6). People with specific HCC subtypes, prior liver transplants, recent serious brain complications, or severe hepatic encephalopathy can't join.

What is being tested?

The study is testing the effectiveness of combining two immunotherapy drugs, Nivolumab and Ipilimumab, against standard treatments Sorafenib or Lenvatinib in improving survival rates for patients. Participants are randomly assigned to receive either the combination treatment or one of the standard care options.

What are the potential side effects?

Nivolumab and Ipilimumab may cause immune-related side effects like rash, diarrhea/colitis, hepatitis, endocrine issues such as thyroid dysfunction; other possible effects include fatigue and infusion reactions. Standard care drugs also have risks including skin problems and high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is advanced liver cancer.

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My liver cancer diagnosis was confirmed through a tissue sample.

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My liver function is slightly impaired.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have at least one measurable tumor that has not been treated.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe liver-related brain issues in the last year.

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My liver cancer is of a specific rare type.

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I have active cancer spread to my brain or its coverings.

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I have had a liver transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nivolumab + IpilimumabExperimental Treatment2 Interventions

Group II: Sorafenib/lenvatinibActive Control2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

Ipilimumab

2014

Completed Phase 3

~3140

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immune checkpoint inhibitors, such as Nivolumab and Ipilimumab, work by blocking proteins that prevent the immune system from attacking cancer cells. Nivolumab targets the PD-1 protein on T cells, while Ipilimumab targets the CTLA-4 protein. By inhibiting these checkpoints, these drugs enhance the body's immune response against cancer cells. This is particularly important for liver cancer patients because the liver's unique immune environment can suppress immune activity, making it challenging to target cancer cells effectively. Enhancing the immune response can potentially lead to better control of tumor growth and improved survival outcomes.