Pattern of Use and Safety/Effectiveness Nivolumab in Oncology Practice
Research type
Research Study
Full title
Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
IRAS ID
208006
Contact name
Toby Talbot
Contact email
Sponsor organisation
Bristol-Myers Squibb
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 8 months, 1 days
Research summary
This is an observational, multicentre, single-arm study in patients treated with nivolumab for the approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the United States (US). Targeted countries in the EU for study participation include Austria, Belgium, France, Germany, Italy, Spain, and the United Kingdom (UK). The study will include a total of 1200 patients and is expected to begin in 2016 and continue through to 2024. Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities. The study will be started in 2016, and data collection will be continued until March 2024. As part of routine care, study investigators will evaluate or ask patients about their disease history, treatment history, and any AEs experienced at the time of patient enrollment and during the study period. No additional medical procedures or in-person clinical visits beyond routine oncology care will be required for the study. Data will be entered into the study electronic Case Report Forms (eCRF). If patients are treated for serious adverse events (SAEs) in other healthcare facilities that are not part of the study, and if compliant with country regulations for human research ethics and privacy, queries will be sent to the healthcare facilities for detailed information about the events, management, and outcomes. Patient follow-up will be continued until the study ends, the patient withdraws from the study, or patient deceases, whichever comes first. During patient follow-up and in cases of lost to follow-up, study staff or investigators will make all efforts to obtain data on patients’ safety experiences, changes in treatment and patient characteristics, and vital status.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
17/EM/0110
Date of REC Opinion
30 Mar 2017
REC opinion
Further Information Favourable Opinion