Study of Nivolumab in patients with Melanoma
Research type
Research Study
Full title
A Single-Arm, Open-Label, Multicentre Clinical Trial with Nivolumab (BMS-936558) for Subjects with Histologically Confirmed Stage III (unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA-4 Monoclonal Antibody.
IRAS ID
158617
Contact name
Paul D Nathan
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2014-001286-28
Clinicaltrials.gov Identifier
Research summary
The sponsor, Bristol-Myers Squibb has developed an investigational drug called Nivolumab (BMS-936558) which is currently being studied in patients with melanoma. Nivolumab is a fully human monoclonal antibody which works by promoting an immune response to recognise tumours as foreign and therefore be attacked by the immune system.
This is a clinical research study for patients that have been diagnosed as having histologically confirmed stage III or IV melanoma which has progressing after received treatment with an anti-CTLA-4 monoclonal antibody. This study will assess the rate, frequency and outcome of adverse events, estimate overall survival and the best overall response.
Approximately 1800 patients from around the world will take part in this study with 150 from the UK. Participants will receive 3mg/kg of nivolumab intravenously every 2 weeks. Each cycle of treatment is 14 days. Participants may continue to receive the study drug for a maximum of 24 months, until their melanoma gets worse (although they may be still be treated under protocol-defined circumstances) or the do not tolerate the treatment. After the treatment ends, participants will continue to be followed up to gather additional information about their melanoma, further treatments, quality of life and survival.
This study involves procedures including: medical history, physical examinations, questionnaires, status assessments, blood tests, pregnancy testing, ECG to measure heart rhythm, heart rate, blood pressure, height, breathing rate and oxygen saturation, temperature, weight, Participants will have CT scan at screening, at visit 12 then as per standard of care.REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/1490
Date of REC Opinion
13 Oct 2014
REC opinion
Further Information Favourable Opinion