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Checkpoint Inhibitor
Nivolumab vs Sorafenib for Liver Cancer
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 time from the date of randomization to the date of the first objectively documented tumor progression or death, assessed up to may 2019 (approximately 40 months)
Awards & highlights
Study Summary
This trial will compare the effectiveness of two drugs, nivolumab and sorafenib, for the treatment of advanced liver cancer.
Who is the study for?
This trial is for adults with advanced liver cancer (Hepatocellular Carcinoma) who have finished any local treatments at least a month ago, are in good physical condition (able to perform daily activities without significant fatigue), and whose liver still works well. People can't join if they've had certain rare types of liver cancer, a previous liver transplant, or an active autoimmune disease.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of two drugs: Nivolumab, which is an investigational immune therapy, and Sorafenib, as initial treatments for advanced Hepatocellular Carcinoma. Patients will be randomly assigned to receive either Nivolumab or Sorafenib.See study design
What are the potential side effects?
Nivolumab may cause immune system-related side effects such as inflammation in various organs like lungs or intestines, skin rash or hormone gland problems. Sorafenib can lead to diarrhea, fatigue, infection risk increase and hand-foot skin reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to may 2019 (approximately 40 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to may 2019 (approximately 40 months)
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
Efficacy Based on PD-L1 Expression - ORR
Efficacy Based on PD-L1 Expression - OS and PFS
Objective Response Rate (ORR) Per BICR RECIST 1.1
+1 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
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%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
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%
Hypertension
7%
Bronchitis
7%
Chills
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
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%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Small intestinal haemorrhage
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Circulatory collapse
1%
Hypercalcaemia
1%
Bronchial obstruction
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
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NivolumabExperimental Treatment1 Intervention
Nivolumab specified dose on specified days
Group II: SorafenibActive Control1 Intervention
Sorafenib specified dose on specified days
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?
Bristol-Myers SquibbLead Sponsor
2,639 Previous Clinical Trials
4,128,289 Total Patients Enrolled
6 Trials studying Liver Cancer
1,438 Patients Enrolled for Liver Cancer
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,780 Total Patients Enrolled
1 Trials studying Liver Cancer
545 Patients Enrolled for Liver Cancer
Bristol Myers SquibbStudy DirectorBristol-Myers Squibb
31 Previous Clinical Trials
31,669 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please list the hospitals in this city that are conducting this research?
"So far, this study has 38 running locations, such as Local Institution - 0019 in Philadelphia, Local Institution - 0044 in Vancouver, and University Of Pennsylvania in Quebec."
Answered by AI
Could you please list the side effects of Nivolumab?
"There is both prior clinical data to support the safety of Nivolumab as well as multiple rounds of data, making it a 3 on our safety scale."
Answered by AI
What are the most similar previous studies to the one involving Nivolumab?
"Nivolumab was first studied in 2005. So far, there have been 639 completed trials and 812 clinical trials are still recruiting patients. Many of these studies are based in Philadelphia."
Answered by AI
What are some of the conditions that Nivolumab has been shown to be effective against?
"Metastatic ureter urothelial carcinoma is most effectively treated with Nivolumab. However, Nivolumab is also a viable treatment option for other conditions such as metastatic hepatocellular carcinoma, malignant melanoma of skin, and previous anti-angiogenic therapy."
Answered by AI
Are there any patients that are still needed for this clinical trial?
"This study is not currently seeking participants. The trial was first posted on December 7th, 2015 and was last updated on October 11th, 2022. However, if you are seeking other studies, there are presently 2686 trials actively looking for participants with carcinoma, hepatocellular and 812 trials for Nivolumab actively looking for participants."
Answered by AI
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