Nivolumab monotherapy/nivolumab+ipilimumab aRCC RWE
Research type
Research Study
Full title
Investigating patient characteristics, treatment pathways and health outcomes in advanced renal cell carcinoma (aRCC) patients treated with nivolumab plus ipilimumab or nivolumab monotherapy
IRAS ID
283338
Contact name
Tom Geldart
Contact email
Sponsor organisation
Bristol-Myers Squibb Pharmaceuticals Ltd.
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
Kidney cancer is one of the most common cancers 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.
RCC is graded into four stages (stage I – IV). When the tumour has spread to nearby tissue or lymph nodes, it is defined as locally advanced RCC, or stage III. When the tumour has spread beyond the regional lymph nodes to other parts of the body (metastasised), it is defined as advanced, or stage IV RCC (aRCC).
Immune checkpoint inhibitors nivolumab (anti programmed cell death protein 1) and ipilimumab (anti cytotoxic T lymphocyte-associated antigen 4) promote an anti-tumour response and are recommended in combination for first line (1L) treatment of untreated aRCC in adults.
Although the efficacy of nivolumab plus ipilimumab has been demonstrated in the clinical trial setting, supporting real-world evidence is limited.
This study aims to generate real-world evidence from clinical practice in UK NHS sites to describe the characteristics, treatment pathways and clinical outcomes of patients with aRCC who received either 1L treatment with nivolumab or nivolumab plus ipilimumab at any line of therapy (LOT). To examine treatment patterns and outcomes during the COVID-19 pandemic, this study will also include patients who received 1L nivolumab, or nivolumab plus ipilimumab at any LOT, for treating aRCC during the pandemic.
The study period will extend from 05 April 2014 to the date of the first study site starts data collection. Data collection will use historic patient records and does 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.
The study is sponsored by Bristol-Myers Squibb Pharmaceuticals Ltd.
REC name
South East Scotland REC 02
REC reference
21/SS/0020
Date of REC Opinion
19 Feb 2021
REC opinion
Favourable Opinion