Nivolumab treatment sequences and outcomes in aRCC patients
Research type
Research Study
Full title
Understanding Treatment Sequences and Outcomes for Patients Treated With Nivolumab Versus Other Agents for Advanced Renal Cell Carcinoma
IRAS ID
257930
Contact name
Tom Waddell
Contact email
Sponsor organisation
Bristol-Myers Squibb Pharmaceuticals Ltd.
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
Kidney cancer is the seventh most common cancer in the UK. More specifically, over 80% of all kidney cancer cases are classified as renal cell carcinoma (RCC). This form of cancer affects the part of the kidneys which filter blood to produce urine.\n\nLike most cancers, RCC is graded into four stages (stage I – IV). Stage III tumours are known as advanced RCC (aRCC), defined as either locally advanced and/or spreading to regional lymph nodes. When the tumour has spread beyond the regional lymph nodes to other parts of the body, it is generally defined as metastatic, or stage IV.\n\nNivolumab is a drug which promotes an anti-tumour response (via blocking programmed cell death protein 1 [PD-1]) and is recommended for the treatment of previously treated aRCC in adults.\nThis study aims to produce evidence on the overall survival (OS), treatment sequences and outcomes of aRCC patients, particularly for patients that have used nivolumab.\n\nThe study will take place in 6 hospital sites across England. Clinical data will be sourced directly from the medical records of patients that have received treatment with nivolumab for the treatment of aRCC at any line of therapy (LOT) between 01 March 2016 – 30 June 2018.\n\nData collection will use historic patient records and not involve direct patient contact. To ensure patient confidentiality, all data will be pseudonymised during data collection and patient identifiable information will not be recorded.\n\nThe study is sponsored by Bristol-Myers Squibb Pharmaceuticals Ltd.\n
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0185
Date of REC Opinion
29 May 2019
REC opinion
Favourable Opinion