Phase 1 of Nivolumab in Advanced HCC
Research type
Research Study
Full title
A Phase I Dose Escalation Study to Investigate the Safety, Immunoregulatory Activity, Pharmacokinetics, and Preliminary Antitumor Activity of Anti-Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Advanced Hepatocellular Carcinoma in Subjects with or without Chronic Viral Hepatitis
IRAS ID
170877
Contact name
Daniel Palmer
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2012-001514-42
Clinicaltrials.gov Identifier
Research summary
This is a multicentre Phase I study investigating the safety and antitumor activity of nivolumab in patients with advanced liver cancer with or without chronic viral hepatitis B (HBV) or C (HCV).
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 allow the body’s immune system to work against tumour cells. Part of this study involves assessing how nivolumab regulates the immune system.
This study involves 3 periods: screening, treatment and follow-up. After screening (lasting up to 28 days), eligible patients are treated every 2 weeks for up to 2 years (depending on response to treatment) and followed up for one year. Eligible patients in the UK will join the treatment expansion phase of the study where a chosen dose will be given.
Patients and doctors will know the medication the patients are assigned. Study procedures include: tumour biopsy/bone scans if required, CTs/ MRIs, ECGs, 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 60 minutes.
After completing all study treatments or after patients are withdrawn from treatment, they will be asked to continue with follow-up visits to monitor for side effects or potential benefits they may experience from nivolumab.
The study will be conducted by trained oncology teams in specialist NHS clinics and is sponsored by Bristol-Myers Squibb.
REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0013
Date of REC Opinion
29 Jan 2015
REC opinion
Further Information Favourable Opinion