Status: Open
Specialty: Renal
Date Opened: 06/05/2022
Planned Close Date: 31/05/2022
Sponsor: BMS
Principal Investigator: Dr Omi Parikh
Study Title: Investigating patient characteristics, treatment pathways and health outcomes in advanced renal cell carcinoma (aRCC) patients treated with nivolumab plus ipilimumab or nivolumab monotherapy
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.
Patients who meet all of the following criteria will be eligible for study inclusion:
• Adult patients (≥ 18 years of age) on date of aRCC diagnosis.
• Initiated on 1L nivolumab, or nivolumab plus ipilimumab (any LOT) for aRCC during the index period.
Patients who meet any of the following criteria will be excluded:
• Patients with malignant primary or secondary tumours in addition to aRCC.
• Patients with incomplete minimum dataset.
• Patients who received nivolumab and/or ipilimumab as part of an investigational study, e.g. clinical trial.
Clinical Trials Coordinator: Samuel Almond (x8475) Samuel.Almond@lthtr.nhs.uk
Nurse oversight: Stephanie Cornthwaite
Link to EDGE