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Checkpoint Inhibitor

Immunotherapy + TACE for Liver Cancer (CheckMate 74W 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights

CheckMate 74W Trial Summary

This trial will compare the safety and effectiveness of adding the immunotherapy drugs nivolumab and ipilimumab to the standard treatment of Trans-arterial ChemoEmbolization (TACE) for intermediate stage liver cancer.

Who is the study for?
This trial is for people with intermediate-stage liver cancer who haven't spread beyond the liver, have no major blood vessel involvement, and are in good physical condition (able to carry out daily activities). They must be suitable for a procedure called TACE. People with autoimmune diseases, prior liver transplants, or certain types of mixed liver cancers cannot join.Check my eligibility
What is being tested?
The study tests the safety and effects of combining nivolumab alone or with ipilimumab (both are immune system-boosting drugs) along with TACE—a targeted chemotherapy treatment—compared to just TACE on its own in treating intermediate-stage liver cancer.See study design
What are the potential side effects?
Nivolumab and ipilimumab can cause immune-related side effects such as inflammation in various organs, skin rash, hormone gland problems like thyroid issues, digestive tract symptoms like diarrhea or colitis, and potential lung issues like pneumonitis.

CheckMate 74W Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 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
Number of deaths in all treated patients
Number of treated participants with adverse events (AEs)
Number of treated participants with laboratory abnormalities
Secondary outcome measures
Event-Free Survival (EFS)
Overall Survival (OS): Arm B versus Arm C
Progression-free survival (PFS)
+1 more

Side effects data

From 2021 Phase 3 trial • 1844 Patients • NCT03068455
38%
Fatigue
37%
Diarrhoea
37%
Pruritus
29%
Headache
28%
Rash
24%
Hypothyroidism
24%
Nausea
20%
Hyperthyroidism
18%
Arthralgia
18%
Cough
18%
Asthenia
15%
Alanine aminotransferase increased
13%
Lipase increased
13%
Pyrexia
12%
Constipation
12%
Aspartate aminotransferase increased
12%
Decreased appetite
12%
Nasopharyngitis
11%
Abdominal pain
11%
Dry mouth
11%
Vomiting
11%
Myalgia
10%
Hypophysitis
10%
Insomnia
10%
Back pain
9%
Amylase increased
8%
Dyspnoea
8%
Upper respiratory tract infection
7%
Dizziness
6%
Adrenal insufficiency
6%
Abdominal pain upper
6%
Infusion related reaction
6%
Hyperglycaemia
6%
Oropharyngeal pain
6%
Blood creatine phosphokinase increased
6%
Influenza like illness
5%
Vitiligo
5%
Hypertension
5%
Pain in extremity
3%
Colitis
3%
Anxiety
2%
Immune-mediated enterocolitis
2%
Autoimmune hepatitis
2%
Basal cell carcinoma
2%
Malignant neoplasm progression
1%
Autoimmune colitis
1%
Squamous cell carcinoma
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Erysipelas
1%
Pneumonia
1%
Melanoma recurrent
1%
Pneumonitis
1%
Sarcoidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Ipi
Arm B: Nivo

CheckMate 74W Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab + TACEExperimental Treatment2 Interventions
Group II: Nivolumab + Ipilimumab + TACEExperimental Treatment3 Interventions
TACE (Trans-arterial ChemoEmbolization)
Group III: TACEActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~4960
ipilimumab
2016
Completed Phase 3
~5520
TACE
2010
Completed Phase 3
~2190

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,488 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: NCT04340193 — Phase 3
Liver Cancer Research Study Groups: Nivolumab + Ipilimumab + TACE, Nivolumab + TACE, TACE
Liver Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04340193 — Phase 3
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04340193 — Phase 3

Frequently Asked Questions

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

What other drugs has nivolumab been tested with in previous clinical trials?

"Nivolumab was first studied at Texas Children's Hospital in 2009. There are a total of 369 completed clinical trials as of now. However, there are 800 clinical trials that are actively recruiting. New york and Kentucky have a significant number of these trials."

Answered by AI

What are the primary maladies that nivolumab has been shown to improve?

"Though it is most often used as a follow-up to anti-angiogenic therapy, nivolumab can also be used to treat squamous cell carcinoma, unresectable melanoma, and other malignant neoplasms."

Answered by AI

Are patients being recruited for this study at this time?

"Although this study was last updated on October 11th, 2022, it is not currently enrolling patients. As of right now, there are 261 other clinical trials for liver cancer and 800 for nivolumab that are still admitting participants."

Answered by AI

Is there a high risk of negative side effects for those taking nivolumab?

"The safety of nivolumab is rated as a 3 by our team at Power. This is because nivolumab is a Phase 3 trial drug, meaning that there is some evidence to support its efficacy, as well as multiple rounds of data supporting its safety."

Answered by AI

Do several hospitals in Canada offer this treatment?

"The trial is being conducted by Local Institution in New york, Kentucky, The Liver Institute at Methodist Dallas Medical Center in Louisville, Pennsylvania, and University of Louisville-James Graham Brown Cancer Center in Philadelphia, Texas. There are also 14 other sites across the country."

Answered by AI

Could you please share how many individuals are enrolled in this clinical trial?

"This study is not currently enrolling patients, as indicated by the dates on the listing. The study was first posted on September 15th, 2020 and was last updated on October 11th, 2020. However, there are 800 other trials involving nivolumab and 261 other trials for patients with liver cancer that are actively recruiting."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
2020. "A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04340193.
~6 spots leftby Apr 2025
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