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Checkpoint Inhibitor

Nivolumab Combinations for Liver Cancer (CheckMate040 Trial)

Phase 1 & 2
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
Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
Must not have
Any history of hepatic encephalopathy
Any prior or current clinically significant ascites
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 9 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of different doses of the immunotherapy drug nivolumab in treating hepatitis C- and B-infected patients with liver cancer, as well as patients who don't have either virus. The study is divided into two parts: first, different doses of nivolumab will be tested in each group to see if it's safe; second, the most effective dose from the first part will be given to a larger group of patients to confirm its effectiveness.

Who is the study for?
Adults with advanced liver cancer not suitable for surgery or other local treatments, or those whose disease progressed after such treatments. Participants must have a good performance status (able to carry out daily activities) and an acceptable liver function score. People with certain infections or poor liver function are excluded.
What is being tested?
The trial is testing Nivolumab alone at different doses and in combination with other drugs like Ipilimumab, Sorafenib, and Cabozantinib in patients with various types of advanced liver cancer including those infected by hepatitis viruses.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, fatigue, skin issues, digestive problems, changes in liver enzymes and hormone levels. The combination of drugs may increase the risk of these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older with advanced liver cancer not suitable for surgery or other local treatments.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of brain issues due to liver disease.
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I have or had significant fluid buildup in my abdomen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 9 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 9 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Complete response (CR) Rate
Disease control rate (DCR)
Duration of response (DOR)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups
Experimental Treatment
Active Control
Group I: Non-infected: NivolumabExperimental Treatment1 Intervention
Nivolumab intravenous solution on specific days
Group II: Nivolumab plus Ipilimumab plus CabozantinibExperimental Treatment1 Intervention
Nivolumab intravenous solution + Ipilimumab intravenous solution + cabozantinib oral tablets on specific days
Group III: Nivolumab plus Ipilimumab CombinationExperimental Treatment2 Interventions
Nivolumab intravenous solution + Ipilimumab intravenous solution on specific days
Group IV: Nivolumab plus Cabozantinib CombinationExperimental Treatment1 Intervention
Nivolumab intravenous solution + cabozantinib oral tablets on specific days
Group V: NivolumabExperimental Treatment1 Intervention
Nivolumab intravenous solution on specific days
Group VI: HCV-infected: NivolumabExperimental Treatment1 Intervention
Nivolumab intravenous solution on specific days
Group VII: HBV-infected: NivolumabExperimental Treatment1 Intervention
Nivolumab intravenous solution on specific days
Group VIII: Child-Pugh BExperimental Treatment1 Intervention
Nivolumab intravenous solution on specific days
Group IX: SorafenibActive Control1 Intervention
Sorafenib tablets on specific days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1760
Ipilimumab
2015
Completed Phase 3
~3070
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdIndustry Sponsor
171 Previous Clinical Trials
95,077 Total Patients Enrolled
1 Trials studying Liver Cancer
545 Patients Enrolled for Liver Cancer
Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,128,910 Total Patients Enrolled
6 Trials studying Liver Cancer
1,439 Patients Enrolled for Liver Cancer

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01658878 — Phase 1 & 2
Liver Cancer Research Study Groups: HCV-infected: Nivolumab, HBV-infected: Nivolumab, Nivolumab, Sorafenib, Nivolumab plus Ipilimumab Combination, Child-Pugh B, Non-infected: Nivolumab, Nivolumab plus Cabozantinib Combination, Nivolumab plus Ipilimumab plus Cabozantinib
Liver Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT01658878 — Phase 1 & 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01658878 — Phase 1 & 2
~51 spots leftby Nov 2025
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