732 Participants Needed

Nivolumab + Ipilimumab for Liver Cancer

(CheckMate 9DW Trial)

Recruiting at 395 trial locations
Fl
Rs
BS
Overseen ByBMS Study Connect Contact Center http://www.bmsstudyconnect.com/
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

BS

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

My condition is advanced liver cancer.
My liver cancer diagnosis was confirmed through a tissue sample.
My liver function is slightly impaired.
See 2 more

Exclusion Criteria

I have had severe liver-related brain issues in the last year.
My liver cancer is of a specific rare type.
There are other requirements that need to be met which are described in the study's guidelines.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either nivolumab plus ipilimumab or standard of care (sorafenib or lenvatinib) as first-line treatment for advanced hepatocellular carcinoma

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ipilimumab
  • Lenvatinib
  • Nivolumab
  • Sorafenib
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab + IpilimumabExperimental Treatment2 Interventions
Group II: Sorafenib/lenvatinibActive Control2 Interventions

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Yervoy for:
  • Advanced melanoma
  • Stage III unresectable melanoma
  • Stage IV metastatic melanoma
🇪🇺
Approved in European Union as Yervoy for:
  • 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

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

In a study of 71 patients with advanced hepatocellular carcinoma, the combination of nivolumab and cabozantinib showed promising antitumor activity, with an objective response rate of 17% for the doublet therapy and 29% for the triplet therapy including ipilimumab.
Both treatment combinations had manageable safety profiles, with 50% of patients in the doublet arm and 74% in the triplet arm experiencing grade 3-4 treatment-related adverse events, but no treatment-related deaths were reported.
Nivolumab Plus Cabozantinib With or Without Ipilimumab for Advanced Hepatocellular Carcinoma: Results From Cohort 6 of the CheckMate 040 Trial.Yau, T., Zagonel, V., Santoro, A., et al.[2023]
Combining nivolumab with ipilimumab results in higher response rates in cancer treatment compared to using nivolumab alone, indicating a potentially more effective therapeutic strategy.
This combination therapy may enhance the immune response against cancer, but specific details on the number of subjects or study duration are not provided in the abstract.
Nivolumab plus Ipilimumab Achieves Responses in dMMR/MSI-H Tumors.[2019]
In a phase 2 trial involving 142 patients with untreated advanced melanoma, the combination of nivolumab and ipilimumab resulted in a 2-year overall survival rate of 63.8%, compared to 53.6% for those receiving ipilimumab alone, suggesting improved survival outcomes with the combination therapy.
However, the combination treatment was associated with a higher incidence of severe side effects, with 54% of patients experiencing grade 3-4 adverse events compared to 20% in the ipilimumab-only group, indicating a trade-off between efficacy and safety.
Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial.Hodi, FS., Chesney, J., Pavlick, AC., et al.[2022]

Citations

Nivolumab Plus Cabozantinib With or Without Ipilimumab for Advanced Hepatocellular Carcinoma: Results From Cohort 6 of the CheckMate 040 Trial. [2023]
Nivolumab plus Ipilimumab Achieves Responses in dMMR/MSI-H Tumors. [2019]
Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. [2022]
Long-term survival with first-line nivolumab plus ipilimumab in patients with advanced non-small-cell lung cancer: a pooled analysis. [2023]
Ipilimumab and nivolumab in advanced hepatocellular carcinoma after failure of prior immune checkpoint inhibitor-based combination therapies: a multicenter retrospective study. [2023]
Clinical Course and Treatment Implications of Combination Immune Checkpoint Inhibitor-Mediated Hepatitis: A Multicentre Cohort. [2022]
Incidence and risk of hepatic toxicities with PD-1 inhibitors in cancer patients: a meta-analysis. [2018]
Liver Toxicity with Cancer Checkpoint Inhibitor Therapy. [2019]
Safety profile of immune checkpoint inhibitors: An analysis of the Italian spontaneous reporting system database. [2021]
Successful mycophenolate mofetil treatment of a patient with severe steroid-refractory hepatitis evoked by nivolumab plus ipilimumab treatment for relapsed bladder cancer. [2021]
European Medicines Agency extension of indication to include the combination immunotherapy cancer drug treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) for adults with intermediate/poor-risk advanced renal cell carcinoma. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Nivolumab/Ipilimumab Combo Yields Durable Efficacy in Advanced NSCLC. [2021]
Feasibility and safety of nivolumab in advanced hepatocellular carcinoma: real-life experience from three German centers. [2020]
14.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial. [2022]
Ipilimumab and nivolumab/pembrolizumab in advanced hepatocellular carcinoma refractory to prior immune checkpoint inhibitors. [2022]
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