The purpose of this study is to describe the real-life use of Cabometyx® in monotherapy or in combination with nivolumab in Belgium in patients with advanced or metastatic Renal Cell Carcinoma (1st, 2nd and later lines of treatment)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Males or females aged 18 years and older
* Patients scheduled to receive Cabometyx® in monotherapy or in combination with nivolumabfor advanced or metastatic renal cell carcinoma
* Decision to treat patients with Cabometyx® in monotherapy or in combination with nivolumab has to be taken prior to and independent from participation in the clinical study
* Provision of written informed consent
Exclusion Criteria:
* Participation in another interventional clinical study at the same time
* Previous participation in this clinical study
Primary outcome measure(s)
Treatment line — Baseline Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment or cabozantinib in monotherapy or in combination with nivolumab as 1st line of treatment.
Dose reductions and reasons — From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop Number of dose reductions and reason
Treatment interruptions and reason — From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop Number of treatment interruptions and reason
Treatment discontinuations and reason — From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop Number of patients with permanent discontinuation and reason
Alternative dose schedule — From baseline until the end of study up to 9 months Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period
Mean number of any dose modification — From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median number of any dose modification — From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median time to any first dose modification — From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median time to end of treatment — From baseline until the end of study up to 9 months
Duration of treatment exposure — From baseline until the end of study up to 9 months
Dose prescribed at initiation — Baseline Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline
Average daily dose — From baseline until the end of study up to 9 months Estimation of average daily dose received by subject during the treatment exposure
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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