Advanced or Metastatic Renal Cell Carcinoma
Conditions
Brief summary
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)
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | From baseline until the end of study up to 9 months | Percent of patients with partial and complete response during the treatment with cabozantinib |
| Disease Control Rate | From baseline until the end of study up to 9 months | Percent of patients with stable disease, partial and complete response during the treatment with cabozantinib |
| Change in Quality of Life score | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop | Changes in quality of life data by comparing changes in scores on Using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NFKSI-19). It describes the severity, interference, and frequency rates. |
| Progression Free Survival (PFS) | From baseline until the end of study up to 9 months | Radiological progression using RECIST 1.1 or investigator assessed or according to local standard of care or death; PFS evaluated at least every 12 weeks under treatment with cabozantinib |
Countries
Belgium
Contacts
STUDY_DIRECTORIpsen Medical Director
Ipsen
Outcome results
None listed