Nivolumab + Ipilimumab for Liver Cancer
(CheckMate 9DW Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the combination of Nivolumab and Ipilimumab generally safe for humans?
The combination of Nivolumab and Ipilimumab can cause immune-related side effects, including liver inflammation (hepatitis), which can be serious. These side effects are not very common but can vary in severity, and sometimes require stopping the treatment and using other medications to manage them.12345
How is the drug combination of nivolumab and ipilimumab unique for liver cancer treatment?
The combination of nivolumab and ipilimumab is unique for liver cancer because it uses two immune checkpoint inhibitors to potentially improve outcomes in advanced hepatocellular carcinoma (HCC), especially for patients who have already been treated with other therapies like sorafenib. This approach may offer a new option for those with advanced disease not eligible for curative treatments.678910
What data supports the effectiveness of the drug combination of Nivolumab and Ipilimumab for liver cancer?
Research shows that the combination of Nivolumab and Ipilimumab has been effective in treating other cancers, like melanoma and lung cancer, by improving survival rates and response rates compared to using each drug alone. Additionally, studies in liver cancer patients suggest that this combination can be beneficial even after other treatments have failed.1112131415
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either nivolumab plus ipilimumab or standard of care (sorafenib or lenvatinib) as first-line treatment for advanced hepatocellular carcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Lenvatinib
- Nivolumab
- Sorafenib
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania