A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults
NCT05361434
Advanced Renal Cell Carcinoma
Brussels, Belgium
View Trial DetailsNCT Number: NCT03696407
Clinical experience with cabozantinib is limited in the UK and Ireland and there is anecdotal evidence of there being variability between clinicians in terms of where cabozantinib is used in the treatment pathway. The present study aims to collate and report the experiences of a sample of National Health Service (NHS) Trusts that enrolled patients onto the managed access programme. The study will describe the positioning of cabozantinib in the treatment pathway, associated clinical outcomes and characteristics of patients with advanced RCC receiving cabozantinib in this early clinical experience setting. The results will provide valuable information for collective learning on how to prescribe and manage cabozantinib and its optimal positioning in the patient pathway. Overall, the findings will contribute to a better understanding of how best to manage patients with advanced RCC in routine practice.
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Notify Me18 year and older
All sexes
Observational
Royal Sussex County Hospital, Brighton, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 months
Positioning of cabozantinib in the treatment pathway (second line, third line, fourth line or above)
Time frame: Baseline
Distribution, mean (SD) and median (quartiles) cabozantinib starting dose.
Time frame: 24 months
Mean (SD) and median (quartiles) cabozantinib daily dose during treatment.
Time frame: 24 months
Proportion of patients with dose modifications and mean (SD) and median (quartiles) number of dose modifications per patient.
Time frame: 24 months
Time frame: 24 months
Time frame: 24 months
Time frame: 24 months
Time frame: 24 months
Time frame: 24 months
Radiation procedures, denosumab, bisphosphonates.
Time frame: 24 months
Time frame: baseline
Time frame: baseline
Mean (SD) and median (quartiles) time (months
Time frame: baseline
Time frame: baseline
Metastatic sites (lung / liver / bone / lymph node / brain / visceral other) documented co-morbidities and distribution of relevant co-morbidities.
Time frame: baseline
Distribution of IMDC risk group (favourable, intermediate, poor). From patient's medical records (if documented) or calculated from the individual components (haemoglobin, Karnofsky Performance Status, time from advanced RCC diagnosis to systemic treatment initiation, calcium, neutrophils, platelets).
Time frame: 3, 6, 9, 12, 18 and 24 months and median PFS.
PFS is defined as the time from cabozantinib initiation until the date of first documented evidence of disease progression or death from any cause. Disease progression is defined as either radiological disease progression (according to RECIST criteria [if documented in routine practice] or other local investigator assessment]) or clinical progression
Time frame: 6, 12, 18 and 24 months
OS will be measured from both cabozantinib initiation (time from cabozantinib initiation until death from any cause) and from advanced RCC diagnosis (from advanced RCC diagnosis until death from any cause).
Time frame: 3, 6, 9 and 12 months
ORR defined as the proportion of patients achieving a complete or partial response
Ipsen
Industry
A Non-interventional Retrospective Study to Describe Early Clinical Experience With Cabozantinib in Patients With Advanced Renal Cell Carcinoma in the United Kingdom (UK)
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