CA209-459 Nivolumab V Sorafenib in HCC
Research type
Research Study
Full title
A Randomized, Multi-center Phase III Study of Nivolumab versus Sorafenib as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 459)
IRAS ID
192888
Contact name
Daniel Palmer
Contact email
Sponsor organisation
Bristol Myers Squibb International Corporation
Eudract number
2015-002740-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 9 months, 7 days
Research summary
Research Summary
This is a multicentre Phase 3 study investigating the safety, effectiveness and tolerability of nivolumab compared to sorafenib in patients with advanced liver cancer. Patients can be included in the study if they have hepatitis B (HBV) or C (HCV), but can also be included if they do not have either of these.
Approximately 726 patients will take part globally with approximately 32 coming from the UK.
Liver cancer or hepatocellular carcinoma (HCC) is diagnosed in over 500,000 people globally and is the fifth most common cancer in men and seventh in women. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will help the body’s immune system to work against tumour cells. Part of this study involves assessing how nivolumab interacts with the immune system.
Sorafenib is one of the accepted treatments that patients would be prescribed in the UK for liver cancer that cannot be removed with surgery.
This study involves 3 periods: screening, treatment and follow-up. After screening (lasting up to 28 days), eligible patients are treated every 2 weeks until worsening of their disease or unacceptable side effects.
Patients and doctors will know the medication the patients are assigned. Study procedures include: tumour biopsy/bone scans if required, CTs/ MRIs, ECGs, echocardiograms, Chest X-Rays, physical examinations, vital signs (e.g. blood pressure, oxygen levels) and bloods for routine safety and study specific testing. Levels of nivolumab in blood samples will be assessed.
Nivolumab will be given by inserting a needle attached to a small tube into a vein in the patient’s arm. A pump will be used to ensure the medicine is given over 30 minutes. Sorafenib will be given in tablet form and taken by mouth twice a day.
After patients are withdrawn from treatment, they will be asked to continue with follow-up visits to monitor for side effects or potential benefits they may experience from nivolumab or sorafenib.
The study will be conducted by trained oncology teams in specialist NHS clinics and is sponsored by Bristol-Myers Squibb.Summary of Results
Lay summary of study results will be provided to the Investigators to pass on to the patients in the form of plain language summary (PLS).
REC name
Wales REC 3
REC reference
16/WA/0014
Date of REC Opinion
11 Feb 2016
REC opinion
Further Information Favourable Opinion