Nivolumab + Ipilimumab for Liver Cancer

(CheckMate 9DW Trial)

Recruiting in Palo Alto (17 mi)

+395 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

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.

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)
• Lenvatinib (Tyrosine Kinase Inhibitor)
• Nivolumab (Checkpoint Inhibitor)
• Sorafenib (Tyrosine Kinase Inhibitor)

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.

Participant Groups

Group I: Nivolumab + Ipilimumab Experimental Treatment 2 Interventions

Group II: Sorafenib/lenvatinib Active Control 2 Interventions

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

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