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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 9 years
Awards & highlights

CheckMate040 Trial 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.Check my eligibility
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.See study design
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.

CheckMate040 Trial 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.

CheckMate040 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ORR for Child-Pugh B Cohort
ORR for Nivolumab plus Ipilimumab Combination Cohort
ORR for Nivolumab plus Ipilimumab plus Cabozantinib Combination Cohort
+8 more
Secondary outcome measures
AUC(TAU) at Cycle 3/ AUC(TAU) at Cycle 1 (AI_AUC) of nivolumab
Area under the serum concentration time curve in the dosing interval AUC(TAU) of nivolumab
Cmax at Cycle 3/ Cmax at Cycle 1 (AI_Cmax) of nivolumab
+15 more

CheckMate040 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
~1080
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,864 Total Patients Enrolled
1 Trials studying Liver Cancer
545 Patients Enrolled for Liver Cancer
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,855 Total Patients Enrolled
6 Trials studying Liver Cancer
1,438 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions is Nivolumab typically administered to address?

"Nivolumab therapy is a viable option for individuals struggling with unresectable melanoma, squamous cell carcinoma, or recurrent high risk cancer."

Answered by AI

To what extent are hospitals participating in this research endeavor?

"The medical trial consists of 14 sites, including Emory University in Atlanta, Saint Joseph's Regional Medical Center in Paterson, and CHUM in Montreal. Other locations are also available."

Answered by AI

Are volunteers being accepted for this experiment at present?

"According to the information on clinicaltrials.gov, this trial is not seeking participants at present. Originally posted on October 30th 2012, with its most recent update occurring December 1st 2021; though it has closed recruitment, there are still 3501 other trials actively recruiting individuals for their studies."

Answered by AI

Is there a record of any prior research conducted on Nivolumab?

"Nivolumab was first tested at Central Illinois Hematology Oncology Center in the year 2005 and 814 trials have been closed. Currently, there are 893 active experiments taking place; a considerable number of these being conducted within Atlanta, Georgia."

Answered by AI

How many participants are being enlisted in this experiment?

"Unfortunately, this trial has ceased enrolling participants. It was posted on October 30th 2012 and the latest update occurred on December 1st 2021. If you are searching for other trials, there exist 2,608 studies recruiting patients with carcinoma and 893 actively looking for individuals taking Nivolumab."

Answered by AI
Recent research and studies
~9 spots leftby Jun 2024