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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
Must not have
Participants previously receiving any prior therapy for HCC, including loco-regional therapies
Any evidence of tumor metastasis or co-existing malignant disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had treatments for liver cancer before.
Select...
My cancer has spread or I have more than one type of cancer.
Select...
My liver cancer is of a specific type (fibrolamellar, sarcomatoid, or mixed).
Select...
I have had a liver transplant or am waiting for one.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~5220

Find a Location

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdIndustry Sponsor
171 Previous Clinical Trials
95,191 Total Patients Enrolled
2 Trials studying Hepatocellular Carcinoma
1,402 Patients Enrolled for Hepatocellular Carcinoma
Bristol-Myers SquibbLead Sponsor
2,681 Previous Clinical Trials
4,124,439 Total Patients Enrolled
20 Trials studying Hepatocellular Carcinoma
5,198 Patients Enrolled for Hepatocellular Carcinoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03383458 — Phase 3
Hepatocellular Carcinoma Research Study Groups: Arm A, Arm B
Hepatocellular Carcinoma 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
~32 spots leftby Apr 2025
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