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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Liver Cancer (CheckMate 9DW Trial)

Phase 3
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
Participants must have an advanced HCC
Participants must have a diagnosis of HCC based on histological confirmation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

CheckMate 9DW Trial Summary

This trial is testing a new combination therapy for liver cancer compared to the current standard of care. The goal is to see if the new therapy can improve survival rates.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Nivolumab and Ipilimumab may cause immune-related side effects like rash, diarrhea/colitis, hepatitis, endocrine issues such as thyroid dysfunction; other possible effects include fatigue and infusion reactions. Standard care drugs also have risks including skin problems and high blood pressure.

CheckMate 9DW Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is advanced liver cancer.
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My liver cancer diagnosis was confirmed through a tissue sample.
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My liver function is slightly impaired.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have at least one measurable tumor that has not been treated.

CheckMate 9DW Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
Overall Survival (OS)
Secondary outcome measures
Duration of Response (DOR)
Objective Response Rate (ORR)
Time to Symptom Deterioration (TTSD)

CheckMate 9DW Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab + IpilimumabExperimental Treatment2 Interventions
Group II: Sorafenib/lenvatinibActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2640

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,629 Previous Clinical Trials
4,125,804 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: NCT04039607 — Phase 3
Liver Cancer Research Study Groups: Sorafenib/lenvatinib, Nivolumab + Ipilimumab
Liver Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04039607 — Phase 3
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04039607 — Phase 3

Frequently Asked Questions

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

Could you tell me if Nivolumab is certified by the FDA?

"Nivolumab is classified as safe due to evidence from Phase 3 trials, which are large-scale studies that show the drug's efficacy and safety."

Answered by AI

What is Nivolumab's efficacy in previous clinical trials?

"There are 1002 active clinical trials studying the effects of Nivolumab. Of these, 137 have reached Phase 3. Most research centres for Nivolumab are located in Pittsburgh, however there are 49831 sites running clinical trials related to Nivolumab worldwide."

Answered by AI

Is there still space available in this trial for willing participants?

"Unfortunately, this particular trial is not currently recruiting. The listing was created on September 30th 2019 but the most recent update occurred on October 27th, 2022. There are presently 2690 studies actively enrolling patients with carcinoma and 1002 studies for Nivolumab that seeking participants."

Answered by AI

Is this research being conducted in various locations around the city?

"Currently, this clinical trial is enrolling patients at the following locations: Rutgers, New jersey Medical School in Newark, New Jersey; Rutgers University New Jersey Medical School in Edmonton, Alberta; and Alberta Health Services in Ann Arbor, Michigan. In addition, there are 5 other sites where recruitment is taking place."

Answered by AI

What are the main conditions that Nivolumab has been FDA approved to target?

"Nivolumab is a common choice for treating unresectable melanoma. Nivolumab has also been shown to be effective in managing squamous cell carcinoma, high risk of recurrence, and disease."

Answered by AI
~244 spots leftby Jul 2026