Observational study in Gastric patients receiving Nivolumab in EAMS
Research type
Research Study
Full title
Early access to medicines scheme – Nivolumab – for gastric and Gastroesophageal Junction (GC/GEJ) Adenocarcinoma Observational Study
IRAS ID
231114
Contact name
Nicholas Maisey
Contact email
Sponsor organisation
Bristol-Myers Squibb Pharmaceuticals Ltd
Duration of Study in the UK
1 years, 5 months, 14 days
Research summary
The purpose of this observational study is to characterise patients with advanced or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma who receive nivolumab after two or more previous treatment regimens within an Early Access to Medicines Scheme (EAMS) in the United Kingdom (UK). Patient characteristics, their treatment patterns, time until their disease progresses, survival status and quality of life will be collected.
This observational study consists of collecting and analysing data from medical records and patient questionnaires for patients enrolled in the EAMS program. Physicians will be asked to provide information on patient demographics, disease characteristics and treatment history at EAMS enrolment, nivolumab treatment patterns as well as disease progression when patients are on treatment and at 6 and 12 months after patients discontinue nivolumab treatment. Patients will be asked to complete a short questionnaire on quality of life, called the EuroQuol Quality of Life 5-Dimensions 3-Levels (EQ-5D), which would be completed by patients at enrolment before they start nivolumab treatment, and then every 2 weeks over a 24 week period following patient enrolment into the EAMS.
The number of patients that will participate in this observational study will depend on the number of patients enrolled into the EAMS from UK hospitals, therefore, it is not possible to provide number of patients at this time.
Data analyses will be descriptive in nature. Patient data will be stored securely without any patient identifiable information so that patient privacy is protected. Study results will be summarised and included in presentations or publications.
REC name
North West - Preston Research Ethics Committee
REC reference
17/NW/0718
Date of REC Opinion
22 Dec 2017
REC opinion
Further Information Favourable Opinion