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Checkpoint Inhibitor

Nivolumab for Liver Cancer (CheckMate 9DX 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 with a first diagnosis of HCC who have undergone a curative resection or ablation
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights

CheckMate 9DX Trial Summary

This trial will test if nivolumab can help prevent cancer from recurring in people who have had surgery or local ablation to remove their tumor, and who are at high risk for the cancer coming back.

Who is the study for?
This trial is for individuals with Hepatocellular Carcinoma (HCC) who have had surgery or ablation and are at high risk of the cancer coming back. It's open to those with non-viral related HCC, HBV-HCC, or HCV-HCC, a good performance status, and no prior treatments for HCC. People can't join if they've had certain types of liver cancer, evidence of spread, previous cancer therapies including transplant or are on a transplant waiting list.Check my eligibility
What is being tested?
The study is testing whether Nivolumab can prevent cancer from returning in patients who've undergone curative treatment for liver cancer compared to a placebo. Participants will be randomly assigned to receive either Nivolumab or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs like lungs and intestines, skin rash, hormone gland problems (like thyroid), fatigue and infusion reactions. The severity of side effects varies among individuals.

CheckMate 9DX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had surgery or ablation for liver cancer as my first treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My liver function is slightly impaired.

CheckMate 9DX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 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
Recurrence-free Survival (RFS)
Secondary outcome measures
Overall Survival (OS)
Time to recurrence (TTR)

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

CheckMate 9DX Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment1 Intervention
Group II: Arm BPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,978 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,969 Total Patients Enrolled
5 Trials studying Liver Cancer
893 Patients Enrolled for Liver Cancer

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03383458 — Phase 3
Liver Cancer Research Study Groups: Arm A, Arm B
Liver Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03383458 — Phase 3
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03383458 — Phase 3

Frequently Asked Questions

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

What are the conditions that Nivolumab is used to treat?

"Nivolumab is most commonly used to treat malignant neoplasms. However, Nivolumab has also been shown to be an effective treatment for unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Has this experiment been tried before?

"As of today, there are 747 ongoing clinical trials for the drug nivolumab in 50 different countries. The first such trial was conducted in 2010 by Medarex and involved 127 patients. It completed its Phase 1 approval stage that year. Since then, 18532 more trials have been conducted worldwide."

Answered by AI

Is this research project still enrolling participants?

"This study isn't recruiting patients right now but was last updated on November 14th, 2022. If you're looking for other studies, there are 3586 trials for carcinoma, hepatocellular and 747 studies involving Nivolumab that are still admitting patients."

Answered by AI

How many people have signed up to participate in this experiment?

"Unfortunately, this study has already closed recruitment. The clinical trial was first announced on April 18th, 2018 and the last update was made on November 14th, 2022. If you are looking for other similar studies, there are currently 3586 trials actively admitting patients with carcinoma and 747 studies for Nivolumab seeking new participants."

Answered by AI

What other drugs have been studied in conjunction with Nivolumab?

"Nivolumab was first brought to H. Lee Moffitt Cancer Center and Research Institute in 2010 for study. As of now, 18532 studies have completed with 747 more presently active. Of these many trials, a great number are based in Anniston, Alabama."

Answered by AI

Is this study widely available to patients in North America?

"For this trial, there are 54 enrolling patients at Pinnacle Research Group, Llc in Anniston, Local Institution - 0273 in Tyler, and Local Institution - 0272 in Austin."

Answered by AI

Nivolumab has been shown to cause adverse effects in some patients, could you please list them?

"Given that this is a phase 3 trial with evidence of efficacy and safety, our team has rated the safety of Nivolumab as a 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
2018. "A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03383458.
All > Hcc > Hepatocellular Carcinoma
~78 spots leftby Apr 2025
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